Medical Policy



Subject: Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation
Document #: TRANS.00016 Current Effective Date:    06/28/2017
Status: Reviewed Last Review Date:    05/04/2017

Description/Scope

This document addresses cord blood banking, which is a process of collecting hematopoietic progenitor stem cells from the umbilical cord and placental blood and cryogenically freezing them immediately after the birthing process.  Both malignant and non-malignant diseases, including genetic diseases, may be treated with cord blood hematopoietic progenitor stem cell transplantation.

Note:  For additional stem cell transplant information and criteria, see the applicable transplant document:

Position Statement

Medically Necessary:

  1. The use of umbilical cord blood progenitor cell transplantation is considered medically necessary for selected individuals when all of the following criteria are met:
    1. One or two donor cord unit(s) is used for a single recipient; and
    2. The total nucleated cell [TNC] count is equal to or greater than 2.3 x 107 per kg; and
    3. The umbilical cord blood stem cell unit(s) is used for an allogeneic stem cell transplant for an approved indication and the appropriate stem cell transplant criteria are met.
  2. Collection and storage of cord blood is considered medically necessary only when an allogeneic transplant is imminent for an identified recipient and the above criteria are met. Storage will only be authorized at centers approved by one of the following:
    1. Foundation for the Accreditation of Cellular Therapy (FACT);
    2. NetCord-FACT;
    3. National Cancer Institute (NCI);
    4. National Marrow Donor Program (NMDP);
    5. AABB (formerly known as American Association of Blood Banks);  
    6. California Department of Public Health.

Investigational and Not Medically Necessary:

The use of umbilical cord blood progenitor cell transplantation is considered investigational and not medically necessary when criterion A is not met.

Prophylactic collection and storage of umbilical cord blood is considered investigational and not medically necessary when proposed for an unspecified future use for an autologous stem cell transplant in the original donor or for an unspecified future use as an allogeneic stem cell transplant in a related or unrelated donor.

Rationale

Cord Stem Cell Transplant
A variety of malignant diseases and non-malignant disorders may be treated with an allogeneic hematopoietic stem cell transplant (HSCT) which involves myeloablative or nonmyeloablative preparative regimens followed by hematopoietic stem cell infusion (HSCI) to restore hematopoietic function and reconstitute the immune system (LeMaistre, 2013).  Hematopoietic progenitor stem cells may be collected from a compatible donor such as a related family member or an unrelated donor identified by the transplant facility.  Donor stem cells from related donors are typically collected by an accredited facility.  Less than 30% of transplant recipients have a human leukocyte antigen (HLA)-identically matched family member that could be a suitable donor.  For individuals without a matched related donor, searches for matching unrelated donors are conducted through nationally recognized and accredited bone marrow and/or hematopoietic stem cell banks (for example, FACT, NetCord-FACT, NMDP) that have passed inspections and demonstrated compliance with the established standards for cellular therapies.  In many cases, a suitable bone marrow donor is not found (Wagner, 2002).  In these situations, suitably matched umbilical cord blood containing hematopoietic progenitor cells may be used as a source of donor cells for HSCT.

There are multiple ongoing studies involving the use of umbilical cord blood as a source of progenitor cells to restore hematopoiesis and bone marrow function to individuals during a stem cell transplant process.  The initial success of utilizing single unit cord blood transplants was noted in pediatric leukemia studies.  Because of the positive pediatric outcomes and the lack of alternatives for adults that require allogeneic stem cell transplant, cord blood stem cell transplants have been performed in adults.  Prospective, randomized studies to assess the efficacy of umbilical cord transplants compared to matched unrelated allogeneic donor transplants are not feasible since cord stem cell transplantation is utilized only when no matched donor is identified.

Neutrophil and platelet engraftment, signs of hematopoietic recovery after umbilical cord blood transplantation, have been delayed in adults when compared to children.  It was determined that the weight of the recipient had a significant influence in the rate of treatment morbidity and mortality.  However, there is insufficient data to determine a maximum weight and the corresponding minimal cell dose based on weight of the recipient.  Authors of studies have noted the use of cord units with lower stem cell counts and the corresponding increased risk of treatment related morbidity and mortality may be options for individuals that have no other source of stem cells (Laughlin, 2001; Parody, 2006; Takahashi, 2006, 2007; Tamura, 2006).

Barker and colleagues (2010) conducted a retrospective analysis of the effect of TNC dosing and HLA match on 1061 individuals who received a single-unit cord blood transplant after myeloablative therapy for leukemia or myelodysplasia.  The authors noted "TNC dose was associated with neutrophil and platelet engraftment in a dose-response relationship with progressively faster and greater engraftment rates as the dose increased."

The evidence from multiple case series studies indicates that the pattern of immune reconstitution with umbilical cord blood is similar to that reported for other stem cell sources and that it is also an effective means for increasing survival rates.  Optimal cell dose also had a positive impact on 5-year overall survival (OS) and disease-free survival (DFS) in children who received umbilical cord transplantation for nonmalignant diseases (Jaing, 2010).

A retrospective analysis of pooled data from 514 individuals transplanted from 1995-2005 with a single unit of unmanipulated cord blood from three international registries was performed by Cohen and colleagues (2011).  The primary mortality rates at 100 days and 1 year, along with 180-day mortality and engraftment failure were analyzed.  Similar mortality rates for all three registries at 1 year were noted with deaths within 100 days of 44% (227 individuals).  Overall Kaplan-Meier survival was 56%, 46% and 37% for 100 day, 180 day and 1 year survival, respectively (Cohen, 2011).  In a review of the potential prognostic factors, the authors noted cell dose less than 2.5 x 107 /kg was associated with poor prognosis.  However, the authors noted the proportion of individuals who received the lower TNC dosing has declined sharply from 1995 (67%) to 2002-2005 (24%).

Rocha and colleagues (2004) performed a retrospective review comparing cord blood stem cell transplants with unrelated bone marrow transplants.  The median TNC of 0.23 X108 per kilogram (kg) was utilized and acceptable transplant outcomes could be achieved in adults.  Although hematopoietic recovery of neutrophils was significantly delayed in the cord blood group (relative risk [RR], 0.49; 95% confidence interval [CI], 0.41 to 0.58; p<0.001), there were no significant differences in the incidence of chronic graft versus host disease (GVHD), leukemia-free survival, relapse rate, and transplant-related mortality (TRM).  Significant differences noted between the two study cohorts included a younger age (median age 24.5 years) for cord blood transplant and an older age (32 years) for unrelated bone marrow transplant.  The cord blood recipients also weighed less with a median weight of 58 kg compared with a median weight of 68 kg for bone marrow recipients.  The cord blood recipients had more extensive disease in 52% compared with 34% in the marrow group.

In reviews of the available data on cord blood, it has been noted there was a "Ten-fold decrease in risk of leukemia relapse in patients with acute leukemia treated with double umbilical cord progenitor cell transplantation compared to patients who received a single unit umbilical cord transplant" (Brunstein, 2007; Tse, 2008).  Brunstein (2007) reported unpublished single institution experience with double cord transplants in the myeloablative setting (n=61) with a probability of disease-free survival and overall survival at 2 years of 55% and 63%.  The author noted there was no significant difference in outcomes when compared to individuals who were treated with the same conditioning regimen, but received a single umbilical cord blood graft.

In a registry outcome study, Rodrigues and colleagues (2009) analyzed 104 adults (mean age of 41 years) transplanted with unrelated donor cord blood cell transplantation.  Twenty-six of these individuals received double umbilical cord blood units.  Chimerism data were available on 17 out of 21 assessable individuals treated with double umbilical cord blood transplants (UCBT).  A total of 94% (16 recipients) had complete chimerism, and 6% (1 recipient) had mixed chimerism.  The cumulative 1 and 2 year incidence of relapse or progression of disease was 31% and 35% respectively.  Double UCBT was associated with lower relapse risk (p=0.02) in the multivariate analysis.  The authors noted UCBT is a viable alternative for adults with advanced lymphoma and chronic lymphocytic leukemia (CLL) who lack an HLA-matched donor.

Wagner and colleagues (2014) compared the 1 year overall survival rate in children and adolescents receiving a double-unit (n=111) or single-unit (n=113) cord blood transplant.  The authors theorized that the greater numbers of hematopoietic cells in two units of cord blood would result in improved transplant outcomes.  In an open-label, phase 3, multicenter, randomized trial, individuals aged 1 to 21 with high risk acute leukemia, chronic myeloid leukemia, or myelodysplastic syndrome received units with at least 2.5×107 nucleated cells per kg in the primary unit and 1.5×107 nucleated cells per kg in a secondary unit.  The overall survival rate at 1 year was 65% (95% CI, 56 to 74) in those receiving two units and 73% (95% CI, 63 to 80) in those receiving a single unit (p=0.17).  The 1-year disease-free survival results were similar: 64% (95% CI, 54 to 72) in double-unit recipients versus 70% (95% CI, 60 to 77) in single-unit recipients (p=0.11).  Both treatment arms were also comparable in regards to several other secondary outcomes including incidences of relapse, treatment-related deaths, neutrophil recovery, infections, immunologic reconstitution, and grade II–IV acute GVHD.  Those who received a single unit did show significantly improved platelet recovery and significantly lower incidences of grade III and IV acute and extensive chronic GVHD.  The study was limited by the fact that individuals were only followed for 1 year; long-term survival was not evaluated.

In an attempt to evaluate risk factors and their effect on outcomes, Chen and associates (2016) performed an analysis of 1404 individuals who received a umbilical cord blood transplantation (UBCT).  Individuals under the age of 18 who received a single unit (n=810) and those 18 and older who received a double unit (n=594) were included.  The authors noted the incidence of acute GVHD is similar to those achieved through conventional sources, however the incidence of chronic GVHD appears to be lower.  The authors also noted that the development of chronic GVHD following a single UBCT was associated with an increase in non-relapse mortality (NRM).  In a double UBCT, chronic GVHD was associated with less disease relapse.

Individual umbilical cord units have variable TNC doses per donated unit.  Attempts to reduce the treatment related morbidity and mortality of umbilical cord stem cell transplant include studies to increase TNC volume through various techniques such as ex vivo cell expansion or haploidentical (haplo) – cord transplantation, which combines both UCB and CD34- selected cells typically from human leukocyte antigen mismatched donors (Van Besien, 2016).  In addition, there is ongoing research to determine the safety and efficacy of using three or more cord units, as well as pooled units of cord blood to provide sufficient TNC doses for transplantation.  At this time, there is a paucity of published literature for the use of three or more umbilical cord units for a single transplant.

Cord Blood Stem Cell Storage
Several public and private cord blood banks have now been developed in Europe and in the United States.  Other for-profit cord blood banks are offering the opportunity of collecting and storing a neonate's cord blood for some unspecified future use in the unlikely event that the child develops a condition that would require autologous transplantation.  In addition, some cord blood is collected and stored from a neonate for use by a sibling in whom an allogeneic transplant is anticipated due to a history of leukemia or other condition requiring allogeneic transplant.  Public cord blood banks collect and maintain donated cords for allogeneic transplants.  Accreditation of most cord blood banks are done by FACT, NMDP and NetCord-FACT (primarily for international centers). 

Purtill and colleagues (2014) reported results of an analysis of 402 cord blood units thawed at a single institution.  The cord blood unit TNC precryopreservation, postthaw and engraftment rates were analyzed.  A total of 350 (87%) out of 402 units were obtained from cord blood banks accredited by NetCord-FACT.  The authors concluded, after "Multivariate analysis, only lack of bank Netcord-FACT accreditation was independently associated with low CD34+ cell recovery."

The indications for autologous umbilical cord stem cell transplantation are limited, and the potential for future expansion is unlikely.  This position is supported by multiple case series.  According to the American Academy of Pediatrics (AAP, 2007), the cord blood of children who later developed leukemia, was found to include DNA mutations.  As a result, transplantation of the autologous cord blood may be contraindicated.  There is no evidence to support the safe and efficacious use of autologous umbilical cord stem cell transplantation.  Therefore, the AAP does not support encouraging the private banking of umbilical cord blood for possible autologous use in the future.  A survey of pediatric transplant physicians (Thornley, 2009) noted few pediatric hematopoietic transplant physicians would "endorse private cord blood banking in the absence of an identified recipient."

The American College of Obstetrics and Gynecology Committee Opinion (2015) provided recommendations which include:

If a patient requests information on umbilical cord banking, balanced and accurate information regarding the advantages and disadvantages of public versus private umbilical cord blood banking should be provided.  The routine storage of umbilical cord blood as "biologic insurance" against future disease is not recommended... Patients should be aware that in certain instances, use of one's own stem cells is contraindicated. Most conditions potentially treated by a patient's own umbilical cord blood already exist in his or her own cells and, therefore, the stored blood cannot be used to treat the same individual. The chance of an autologous unit of umbilical cord blood being used for a child or a family member is remote, unless a family member is known to have a medical condition that could be treated with transplant, and this fact should be disclosed to the patient. Directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation.

In a report (Ballen, 2008) for the American Society for Blood and Marrow Transplantation (ASBMT), the authors have published the following recommendations regarding public and private banking of umbilical cord blood:

  1. A sibling of the expected child has a disease that can be successfully treated with hematopoietic stem cell transplantation (HSCT).
  2. The parent of the expected child has a disease that can be successfully treated with HSCT, and there are shared HLA antigens between the parents.
  3. The expectant parents should be encouraged to donate their newborn's cord blood to a public bank when possible.
  4. Expectant parents should be informed that, although private cord banking is available for purchase, the chance of personally stored cord blood being of benefit to their child is extremely low (about the same chance of maternal death during childbirth), and that current knowledge is limited as to the long-term cord blood viability and the likelihood of success of autologous cord blood transplantation.

Given the lack of scientific data and difficulty in estimating the need for using one's own cord blood cells for transplantation, there is a paucity of evidence to support the private storage of cord blood for "biological insurance."

Background/Overview

In recent years, umbilical cord blood has been used successfully to treat a variety of genetic, hematologic and oncologic disorders.  An estimated 30,000 individuals with malignant and non-malignant diseases have undergone hematopoietic stem cell transplantation with unrelated-donor umbilical cord blood since 1993 (Wagner, 2014).  It has been shown that umbilical cord blood contains a large number of hematopoietic stem cells.

Blood harvested from the umbilical cord and placenta shortly after delivery of a neonate contains stem and progenitor cells capable of restoring hematopoietic function after myeloablative therapy.  Cord blood is being used as an alternative source of allogeneic stem cells when a suitable donor is unavailable.  Cord blood is readily available and is thought to be antigenically "naïve," hopefully minimizing the incidence of graft-versus-host disease (GVHD) and permitting the broader use of unrelated cord blood transplants.

Two characteristics that can influence the outcome of cord blood transplantation are the dose of cells infused and the recipient's weight.  It is widely accepted that the dose of cells infused is a major factor contributing to durable long-term engraftment of bone marrow or peripheral blood stem cells.  The minimal cell dose needed is variable, depending on parameters that include the preparative regimen used for marrow ablation, the nature of the underlying disease, the degree of immunologic mismatch between donor and recipient, and the source of stem cells to be used.  Smaller volumes of cord blood and, thus, fewer nucleated cells can be harvested from the umbilical cord and placenta of a single neonate than is possible when bone marrow or peripheral blood stem cells are obtained from adults.

Private, for-profit companies offer fee-based services to harvest, process, and store cord blood stem cells for possible autologous use.  However, empirical evidence that children will benefit from the use of their own cord blood in the future use is lacking.  Several states have their own licensing requirements which apply to facilities which collect or store cord blood.

Definitions

Allogeneic: Stem cells harvested from a histocompatible donor. (Note: this document does not require a specific level of histocompatibility be present as part of the medical necessity evaluation).

Autologous: Stem cells harvested from the individual's own umbilical cord blood.

Chimerism: Cell populations derived from different individuals; may be mixed or complete.

Ex vivo: Occurring outside of the living body. Refers to a medical procedure in which an organ, cells, or tissue are taken from a living body for a treatment or procedure, and then returned to the living body.

Foundation for the Accreditation of Cellular Therapy (FACT): A non-profit corporation that performs voluntary inspection and accreditation in the field of cellular therapy. Co-founders are the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT). 

Hematologic: Relating to hematology, a branch of medical science that studies blood and blood forming tissues.

Hematopoietic stem cells: Cells that give rise to distinct daughter cells, one cell that replicates the stem cell and one cell that will further proliferate and differentiate into a mature blood cell.

Malignant: Cancerous tissue or cells.

National Marrow Donor Program (NMDP): A non-profit organization that operates a registry for hematopoietic stem cell and umbilical cord blood units.  NMDP coordinates with a network of registered organizations to collect, store, transfer and transplant hematopoietic stem cell and umbilical cord blood units.

NetCord-FACT: A non-profit association of international umbilical cord blood banks. NetCord collaborates with FACT to sponsor standards and accreditation for cord blood banks.

Oncologic: Pertaining to cancer.

Prophylactic collection and storage of umbilical cord blood: Collection and storage of umbilical cord blood without an imminent transplant for an identified recipient.

Umbilical or placental cord blood: Blood taken post-partum from the umbilical cord or placenta.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT  
38207 Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage [when specified as cord blood]
38208-38209 Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest [when specified as cord blood]
38240 Bone marrow or blood-derived peripheral stem cell transplantation; allogeneic [when specified as cord blood]
   
HCPCS  
S2140 Cord blood harvesting for transplantation; allogeneic  
   
ICD-10 Procedure    
30230X1 Transfusion of nonautologous cord blood stem cells into peripheral vein, open approach  
30233X1 Transfusion of nonautologous cord blood stem cells into peripheral vein, percutaneous approach  
30240X1 Transfusion of nonautologous cord blood stem cells into central vein, open approach  
30243X1 Transfusion of nonautologous cord blood stem cells into central vein, percutaneous approach  
30250X1 Transfusion of nonautologous cord blood stem cells into peripheral artery, open approach  
30253X1 Transfusion of nonautologous cord blood stem cells into peripheral artery, percutaneous approach  
30260X1 Transfusion of nonautologous cord blood stem cells into central artery, open approach  
30263X1 Transfusion of nonautologous cord blood stem cells into central artery, percutaneous approach  
6A550ZT Pheresis of cord blood stem cells, single  
6A551ZT Pheresis of cord blood stem cells, multiple  
     
ICD-10 Diagnosis    
  All diagnoses  
       

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:

ICD-10 Procedure  
30230X0 Transfusion of autologous cord blood stem cells into peripheral vein, open approach
30233X0 Transfusion of autologous cord blood stem cells into peripheral vein, percutaneous approach
30240X0 Transfusion of autologous cord blood stem cells into central vein, open approach
30243X0 Transfusion of autologous cord blood stem cells into central vein, percutaneous approach
30250X0 Transfusion of autologous cord blood stem cells into peripheral artery, open approach
30253X0 Transfusion of autologous cord blood stem cells into peripheral artery, percutaneous approach
30260X0 Transfusion of autologous cord blood stem cells into central artery, open approach
30263X0 Transfusion of autologous cord blood stem cells into central artery, percutaneous approach
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Ballen KK, Koreth J, Chen YB, et al. Selection of optimal alternative graft source: mismatched unrelated donor, umbilical cord blood, or haploidentical transplant. Blood. 2012; 119(9):1972-1980.
  2. Ballen KK, Spitzer TR, Yeap BY, et al. Double unrelated reduced-intensity umbilical cord blood transplantation in adults. Biol Blood Marrow Transplant. 2007; 13(1):82-89.
  3. Barker JN, Fei M, Karanes C, et al; RCI BMT 05-DCB Protocol Team. Results of a prospective multicentre myeloablative double-unit cord blood transplantation trial in adult patients with acute leukaemia and myelodysplasia. Br J Haematol. 2015; 168(3):405-412.
  4. Barker JN, Scaradavou A, Stevens CE. Combined effect of total nucleated cell dose and HLA-match on transplantation outcome in 1061 cord blood recipients with hematological malignancies. Blood. 2010; 115(9): 1843-1849.
  5. Barker, JN, Weisdorf DJ, DeFor TE, et al. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003; 102(5):1915-1919.
  6. Barker, JN, Weisdorf DJ, DeFor TE, et al. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005; 105(3):1343-1347.
  7. Brunstein CG, Baker KS, Wagner JE. Umbilical cord blood transplantation for myeloid malignancies. Curr Opin Hematol. 2007; 14(2):162-169.
  8. Chan KW, Grimley MS, Taylor C, Wall DA. Early identification and management of graft failure after unrelated cord blood transplantation. Bone Marrow Transplant. 2008; 42(1):35-41.
  9. Chen YB, Wang T, Hemmer MT, et al. GvHD after umbilical cord blood transplantation for acute leukemia: an analysis of risk factors and effect on outcomes. Bone Marrow Transplant. 2017; 52(3):400-408.
  10. Cohen YC, Scaradavou A, Stevens CE, et al. Factors affecting mortality following myeloablative cord blood transplantation in adults: a pooled analysis of three international registries. Bone Marrow Transplant. 2011; 46(1):70-76.
  11. Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006; 354(17):1813-1826.
  12. Delaney M, Cutler CS, Haspel RL, et al. High resolution HLA matching in double-umbilical-cord-blood reduced-intensity transplantation (CDBT) in adults. Transfusion. 2009; 49(5):995-1002.
  13. Ebrahim GJ. Umbilical cord blood – a rich source of hematopoietic stem cells. J Trop Pediatr. 2002; 48(2):64-65.
  14. Frangoul H, Wang L, Harrell FE, et al. Unrelated umbilical cord blood transplantation in children with immune deficiency: results of a multicenter study. Bone Marrow Transplant. 2010; 45(2):283-288.
  15. Gluckman E. Hematopoietic stem-cell transplants using umbilical cord blood. N Engl J Med. 2001; 344(24):1860-1861.
  16. Gluckman E, Ruggeri A, Rocha V, et al.; Eurocord, Netcord, World Marrow Donor Association and National Marrow Donor Program. Family-directed umbilical cord blood banking. Haematologica. 2011; 96(11):1700-1707.
  17. Jaing TH, Chen SH, Tsai MH, et al. Transplantation of unrelated donor umbilical cord blood for nonmalignant diseases: a single institution's experience with 45 patients. Biol Blood Marrow Transplant. 2010; 16(1):102-107.
  18. Kaimal AJ, Smith CC, Laros RK Jr, et al. Cost-effectiveness of private umbilical cord blood banking. Obstet Gynecol. 2009; 114(4):848-855.
  19. Kurtzberg J, Martin P, Chao N, et al. Unrelated placental blood in marrow transplantation. Stem Cells. 2000; 18(2):153-154.
  20. Laughlin, MJ, Barker J, Bamback B, et al. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001; 344(24):1815-1822.
  21. Laughlin, MJ, Eapen M, Rubinstein P, et al. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004; 351(22):2265-2275.
  22. LeMaistre CF, Farnia S, Crawford S, et al. Standardization of terminology for episodes of hematopoietic stem cell patient transplant care. Biol blood Marrow Transplant. 2013; 19(6):851-857.
  23. Mao, P, Wang S, Wang S, et al. Umbilical cord blood transplant for adult patients with severe aplastic anemia using anti-lymphocyte globulin and cyclophosphamide as conditioning therapy. Bone Marrow Transplant. 2004; 33(1):33-38.
  24. Nishihira H, Kato K, Isoyama K, et al. The Japanese cord blood bank network experience with cord blood transplantation from unrelated donors for haematological malignancies: an evaluation of graft-versus-host disease prophylaxis.  Br J Haematol. 2003; 120(3):516-522.
  25. Parody R, Martino R, Rovira M, et al. Severe infections after unrelated donor allogeneic hematopoietic stem cell transplantation in adults: comparison of cord blood transplantation with peripheral blood and bone marrow transplantation. Biol Blood Marrow Transplant. 2006; 12(7):734-748.
  26. Purtill D, Smith K, Devlin S, et al. Dominant unit CD34+ cell dose predicts engraftment after double-unit cord blood transplantation and is influenced by bank practice. Blood. 2014; 124(19):2905-2912.
  27. Rocha V, Labopin M, Sanz G, et al. Transplants of umbilical-cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004; 351(22):2276-2285.
  28. Rodrigues CA, Sanz G, Brunstein CG, et al. Analysis of risk factors for outcomes after unrelated cord blood transplantation in adults with lymphoid malignancies: a study by the Eurocord-Netcord and Lymphoma Working Party of the European Group for Blood and Marrow Transplantation. J Clin Oncol. 2009; 27(2):256-263.
  29. Scaradavou A, Brunstein CG, Eapen M, et al. Double unit grafts successfully extend the application of umbilical cord blood transplantation in adults with acute leukemia. Blood. 2013; 121(5):752-758.
  30. Takahashi S, Ooi J, Tomonari A, et al. Posttransplantation engraftment and safety of cord blood transplantation with grafts containing relatively low cell doses in adults. Int J Hematol. 2006; 84(4):359-362.
  31. Tamura K, Kawano F, Etoh T, et al. Retrospective analysis of cord blood transplantation on 62 adult patients with advanced hematological malignancies. Fukuoka Igaku Zasshi. 2006; 97(6):175-182.
  32. Thomson BG, Robertson KA, Gowan D, et al. Analysis of engraftment, graft-versus-host diseases, and immune recovery following unrelated donor cord blood transplantation. Blood. 2000; 96(8):2703-2711.
  33. Thornley I, Eapen M, Sung L, et al. Private cord blood banking: experiences and views of pediatric hematopoietic cell transplantation physicians. Pediatrics. 2009; 123(3):1011-1017.
  34. Tse W, Bunting KD, Laughlin MJ. New insights into cord blood stem cell transplantation. Curr Opin Hematol. 2008; 15(4):279-284.
  35. Van Besien K, Childs R. Haploidentical cord transplantation-The best of both worlds. Semin Hematol. 2016; 53(4):257-266
  36. Wagner JE, Barker JN, DeFor TE, et al. Transplantation of unrelated donor umbilical cord blood in 102 patients with malignant and non-malignant diseases: influences of CD34 cell dose and HLA disparity on treatment-related mortality and survival. Blood. 2002; 100(5):1611-1618.
  37. Wagner JE Jr, Eapen M, Carter S, et al.; Blood and Marrow Transplant Clinical Trials Network. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. 2014; 371(18):1685-1694.
  38. Walters MC, Quirolo L, Trachtenberg, ET, et al. Sibling donor cord blood transplantation for thalassemia major: experience of the sibling donor cord blood program. Ann. NY Acad Sci. 2005; 1054:206-213.
  39. Zhang H, Chen J, Que W. A meta-analysis of unrelated donor umbilical cord blood transplantation versus unrelated donor bone marrow transplantation in acute leukemia patients. Biol Blood Marrow Transplant. 2012; 18(8):1164-1173.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Pediatrics Section on Hematology/Oncology; American Academy of Pediatrics Section on Allergy/Immunology; Lubin BH, Shearer WT. Cord blood banking for potential future transplantation. Pediatrics. 2007; 119(1):165-170.
  2. American College of Obstetricians and Gynecologists. Committee Opinion No. 648. Umbilical cord blood banking. Obstetrics & Gynecology. 2015; 126(6):e127-129.
  3. Ballen KK, Barker JN, Steward SK, et al. ASBMT Committee Report. Collection and preservation of cord blood for personal use. Biol Blood and Marrow Transplantation. 2008; 14(3):356-363.
Websites for Additional Information
  1. American Cancer Society. Available at: http://www.cancer.org/. Accessed on March 31, 2017.
  2. The National Marrow Donor Program. Available at: http://bethematch.org/Transplant-Basics/Cord-blood-and-transplants/. Accessed on March 31, 2017.
  3. U.S. Department of Health and Human Services.
Index

Allogeneic Stem Cell Transplant
Autologous Stem Cell Transplant
Cord Blood
Cord Blood as a Source of Stem Cells
Cord Blood Banking
Hematopoietic Stem Cell
Stem Cell Transplant
Umbilical and Placental Cord Blood for Stem Cell Transplant

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History
Status Date Action  
Reviewed 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.  
Reviewed 05/03/2017 Hematology/Oncology Subcommittee review. Updated Rationale, Background, References and Websites sections. Updated formatting in Position Statement section.  
Reviewed 05/05/2016 MPTAC review.  
Reviewed 05/04/2016 Hematology/Oncology Subcommittee review. Updated Rationale, Background/Overview, References and Websites Sections. Removed ICD-9 codes from Coding section.
Revised 05/07/2015 MPTAC review.
Revised 05/06/2015 Hematology/Oncology Subcommittee review. Deleted "accreditation bodies" from medically necessary statement #2. Added two additional entities to medically necessary statement #2. Updated Rationale, References and Websites Sections.
Reviewed 05/15/2014 MPTAC review.
Reviewed 05/14/2014 Hematology/Oncology Subcommittee review. Updated Rationale, References and Websites Sections.
Reviewed 05/09/2013 MPTAC review.
Reviewed 05/08/2013 Hematology/Oncology Subcommittee review. Updated References and Websites.
Reviewed 05/10/2012 MPTAC review.
Reviewed 05/09/2012 Hematology/Oncology Subcommittee review. Updated Rationale, References and Websites.
Revised 05/19/2011 MPTAC review.
Revised 05/18/2011 Hematology/Oncology Subcommittee review. Updated accreditation bodies information in medically necessary criteria. Updated Rationale, References and Websites.
Reviewed 05/13/2010 MPTAC review.
Reviewed 05/12/2010 Hematology/Oncology Subcommittee review. Updated rationale, references and websites.
Revised 05/21/2009 MPTAC review.
Revised 05/20/2009 Hematology/Oncology Subcommittee review. Modify medically necessary criteria to allow one or two umbilical cord units. Updated rationale, coding, references and websites.
Reviewed 11/20/2008 MPTAC review.
Reviewed 11/19/2008 Hematology/Oncology Subcommittee review. Updated rationale, coding, references and websites.
Revised 11/29/2007 MPTAC review.
Revised 11/28/2007 Hematology/Oncology Subcommittee review. Clarified single donor cord unit in medical necessity statement. Added criteria to include, "The patient does not have a human leukocyte antigen (HLA) - matched donor." Updated rationale and references. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
  05/17/2007 Added note to the description section, cross referencing additional documents.
Revised 12/07/2006 MPTAC review.
Revised 12/06/2006 Hematology/Oncology Subcommittee review. References updated. Clarification of medical necessity statement. Reviewed issue of double cords.
Reviewed 12/01/2005 MPTAC review. 
Reviewed 11/30/2005 Hematology/Oncology Subcommittee review. Reviewed issue of double cords.  No change in position statement.
Revised 04/28/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
       
Pre-Merger Organizations Last Review Date Document Number Title

Anthem, Inc.

 

09/18/2003 TRANS.00016 Collection and Storage of Cord Blood as a Source of Stem Cells
WellPoint Health Networks, Inc. 12/02/2004 7.11.01 Umbilical Cord Blood Progenitor Cell Transplantation