Coverage Policy Manual
Policy #: 1998089
Category: Surgery
Initiated: February 1998
Last Review: August 2018
  Cord Blood as a Source of Stem Cells for Treatment of Identified (Diagnosed) Disease

Description:
This policy addresses the collection, storage, and transplantation of placental/umbilical cord blood (“cord blood”) as a source of stem cells for allogeneic stem-cell transplantation. Potential indications for use of cord blood are included in the disease-specific reference policies.
 
Background
A variety of malignant diseases and nonmalignant bone marrow disorders are treated with myeloablative therapy followed by infusion of allogeneic stem and progenitor cells collected from immunologically compatible donors, either from family members or an unrelated donor identified through a bone marrow donor bank. In some cases, a suitable donor is not found.
 
Blood harvested from the umbilical cord and placenta shortly after delivery of neonates contains stem and progenitor cells capable of restoring hematopoietic function after myeloablation. This “cord” blood has been used as an alternative source of allogeneic stem cells. Cord blood is readily available and is thought to be antigenically “naive,” thus hopefully minimizing the incidence of graft-versus-host disease (GVHD) and permitting the broader use of unrelated cord blood transplants. Unrelated donors are typically typed at low resolution for human leukocyte antigens (HLA) -A and -B and at high resolution only for HLA-DR; HLA matching at 4 of 6 loci is considered acceptable. Under this matching protocol, an acceptable donor can be identified for almost any patient (Godley, 2010). Several cord blood banks have now been developed in Europe and in the U.S.
 
Regulatory Issues
The U.S. Food and Drug Administration (FDA) requires licensing of establishments and their products for unrelated-donor allogeneic transplant of minimally manipulated placental and umbilical cord blood stem cells. Facilities that prepare cord blood units only for autologous or related-donor transplants are required to register and list their products, adhere to Good Tissue Practices issued by the FDA, and use applicable processes for donor suitability determination.
 
As with any biologic product, there are issues unique to cord blood as an unrelated donor source; some of these are as follows:
  • Cell dose available is much closer to the minimum needed for engraftment
  • Interbank variability in the quantification of hematopoietic potential
  • Donors who may have hematologic/immunologic disorders may not have manifested their disease at the time of donation or follow-up
  • Units may have been banked years earlier at a time when the collection and storage process may not have reflected current accreditation standards, and,
  • The initial product characterization at the end of processing may not reflect the product at the time of release due to freeze, storage, or transport insults (Wall, 2010).
 
For the reasons cited above, instituting standards and accreditation for cord blood banks is critical. This will assist transplant programs in knowing whether individual banks have important quality control measures in place to address such issues as monitoring cell loss, change in potency, and prevention of product mix-up (Wall, 2010). Two major organizations are working toward these accreditation standards; NetCord/FACT and the American Association of Blood Banks (AABB). NetCord, Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented a program of voluntary inspection and accreditation for cord blood banking. In September 2012, NetCord and FACT released the fifth edition of international standards for cord blood collection, banking and release (NetCord-FACT, 2012). The voluntary program includes standards for collection, testing, processing, storage, and release of cord blood products. As of August 2013, 27 blood banks in the U.S. have been accredited, along with 45 international sites (AAAB, 2013).
 
The U.S. Food and Drug Administration intends to regulate cord blood banking by requiring Biologic License Applications and/or Investigational New Drug applications by October 2011 for any bank that will supply units to patients in the United States. With the international exchange of cord blood units being integral to the availability of a matched unit, it is unclear how this change will affect the practice of acquiring cord blood units (Barker, 2011).
 

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For  Contracts Without Primary Coverage Criteria
 
Transplantation of cord blood stem cells from related or unrelated donors meets primary coverage criteria for effectiveness for recipients  with an appropriate indication for allogeneic stem cell transplant but without a hematopoietic stem-cell donor.
 
Collection and storage of cord blood from a neonate meets primary coverage criteria when an allogeneic transplant is imminent in an identified recipient with a diagnosis that is consistent with the possible need for an allogeneic transplant.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of transplantation of cord blood stem cells from related or unrelated donors for recipients without an appropriate indication for allogeneic stem cell transplant does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of transplantation of cord blood stem cells from related or unrelated donors for recipients without an appropriate indication for allogeneic stem cell transplant is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
(See separate policy on Cord Blood Stem Cells for Unspecified Future Use (2005005) for coverage of the collection of cord and/or placental blood stem cells for future use when there is no identified recipient with a diagnosis that is consistent with the possible need for an allogeneic transplant).

Rationale:
At its inception, placental and umbilical cord blood were used primarily in children due to concerns that the volume of harvested cells would not support hematopoiesis in larger individuals.
 
The available data show that hematopoietic recovery, as measured by neutrophil and platelet engraftment, is somewhat slower and less frequent among adults than among younger patients when placental or cord stem cells are used. Nevertheless, neutrophil counts are restored in the majority (74%–91%) of adult patients.
 
Acute and chronic graft-versus-host disease and early mortality also are somewhat more frequent among adults than among younger patients given placental or cord stem cells. However, for adult patients who require urgent transplant and are unable to wait for a protracted donor search, the available data that show survival 1 year after placental or cord stem-cell transplant is not worse than survival 1 year after an allogeneic stem-cell transplant from an unrelated donor.
 
2003 Update
A review of the peer-reviewed literature on Medline for the period of 2002 through February 2003 found no new clinical trials on the use of placental and umbilical cord blood as a source of stem cells. Therefore, the policy statement is unchanged.
 
2009 Update
A PubMed search was done through November, 2009.  A number of review articles (Brunstein 2007, Cutler 2009, Ooi 2009, Sauter 2008, Stanevsky 2009, Rocha 2006), and a retrospective study of 30 adult patients, were identified.
 
A meta-analysis of pooled nonrandomized comparative studies by Hwang (2007) confirmed that unrelated donor cord blood transplantation (UCBT) in children and adults had consistently equivalent survival outcomes compared with unrelated donor bone marrow transplantation (UBMT) despite greater donor-recipient HLA disparity with UCBT.
 
Results of a prospective phase 2 multicenter trial enrolling 191 children with hematologic malignancies was reported by Kurtzberg and colleagues in 2008.  The median time to engraftment (ANC > 500 mm3 and platelets 50,000/µL) was 27 and 174 days.  The cumulative incidence of neutrophil engraftment by day 42 was 79.9% (95% CI, 75.1%-85.2%); acute grades III/IV GVHD by day 100 was 19.5% (95% CI, 13.9%-25.5%); and chronic GVHD at two years was 20.8% (95% CI, 14.8%-27.7%).  The cumulative incidence of relapse at two years was 19.9% (95% CI, 14.8%-25.7%).
 
There are multiple on-going trials of cord blood transplantation in children and adults, with myeloablative or reduced-intensity conditioning, in various combinations of drugs for hematological disorders, both malignant and nonmalignant.  The search term “cord blood” in www.clinicaltrial.gov resulted in the identification of 166 open studies.
 
2012 Update
A literature search of the MEDLINE database was conducted through August 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.
 
In 2012, Zhang and colleagues published a meta-analysis of studies comparing unrelated donor cord blood transplantation to unrelated donor bone marrow transplantation in patients with acute leukemia (Zhang, 2012). The authors identified 7 studies with a total of 3,389 patients. Pooled rates of engraftment failure (n=5 studies) were 127 events in 694 patients (18%) in the cord blood transplantation group and 57 events in 951 patients (6%) in bone marrow transplantation patients. The rate of engraftment graft failure was significantly higher in cord blood transplantation recipients, p<0.0001. However, rates of acute GVHD were significantly lower in the group receiving cord blood transplantation. Pooled rates of GVHD (n=7 studies) were 397 of 1,179 (34%) in the cord blood group and 953 of 2,189 (44%) in the bone marrow group, p<0.0001. Relapse rates, reported in all studies, did not differ significantly between groups. Several survival outcomes including overall survival, leukemia-free survival and non-relapse mortality favored the bone marrow transplantation group. A 2013 study compared survival rates after bone marrow transplantation or unrelated cord blood transplantation in patients older than age 50 years with acute myelogenous leukemia who received reduced-intensity conditioning. (20) The adjusted 3-year overall survival rate was 51% (95% confidence interval [CI]: 38-63%) after related donor bone marrow transplantation, 53% (95% CI: 28-78%) after unrelated donor bone marrow transplantation and 45% (95% CI: 31-58) after unrelated donor cord blood transplantation; the difference among groups was not statistically different, p=0.73.
 
In 2013, Scaradavou and colleagues reported a retrospective analysis using data from the Center for International Blood and Marrow Transplant Research (CIBMTR) and the U.S.-based National Cord Blood Program (Scaradavou, 2013). The authors reported data on adults with acute leukemia who received 1 (n=106) or 2 (n=303) umbilical cord blood units. All units used for single transplantation contained a minimum cell dose of 2.5–3.0 X 107 nucleated cells/kg. For the double transplants, the 2 units combined contained more than 2.5–3.0 X 107 nucleated cells/kg, but in about half of cases, individual units contained less than the minimum amount required. In analyses adjusting for factors associated with outcomes, rates of transplantation-related mortality (hazard ratio [HR]: 0.91, p=0.63), relapse (HR: 0.90, p=0.64) and overall mortality (HR: 0.93, p=0.62) were similar in the groups that received single and double transplantations. For patients treated in the earlier period, 2002-2004, there was a significantly higher risk of grade 2-4 acute GVHD in recipients of double cord blood units (HR: 6.14, 95% CI: 2.54-14.87, p<0.001). In the later period, 2004-2009, rates of grade 2-4 acute GVHD did not differ significantly between groups (HR: 1.69, 95% CI: 0.68-4.18, p=0.30).
 
Ongoing Clinical Trials
Single Versus Double Umbilical Cord Blood Transplantation in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501) (NCT00412360): This RCT is comparing single or double cord blood unit transplantation for treating children with high-risk leukemia and myelodysplasia. The primary study outcome is overall survival. The expected enrollment is 224 patients and the expected date of study completion is May 2015.
 
A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission (NCT01067300): This RCT is comparing single or double cord blood unit transplantation in children and young adults (younger than than age 35 years) with acute leukemia in remission. The primary outcome measure is the incidence of transplantation failure. The expected enrollment is 198 patients and the expected date of study completion is September 2013.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2014 study by Liu et al compared outcomes after unrelated donor cord blood transplantation versus matched-sibling donor peripheral blood transplantation (Liu, 2014). The study included patients age 16 years or older who had hematologic malignancies. A total of 70 patients received unrelated cord blood and 115 patients received HLA-identical peripheral blood stem cells, alone or in combination with bone marrow. Primary engraftment rates were similar in the 2 groups, 97% in the cord blood group and 100% in the peripheral blood stem-cell group. Rates of most outcomes, including grades III to IV acute GVHD and 3-year disease-free survival were also similar between groups. However, the rate of chronic GVHD was lower in the unrelated-donor cord blood group. Specifically, limited or extensive chronic GVHD occurred in 12 of 58 (21%) evaluable patients in the cord blood group and 46 of 109 (42%) evaluable patients in the peripheral blood stem cell group, p=0.005.
 
Studies have identified the importance of a minimum cell dose. For example, a 2013 analysis of data from the Korean Cord Blood Registry found that the presence of at least 3.91 X 105/kg of infused CD34+ cells was significantly associated with overall survival (p=0.03) in unrelated donor cord blood transplants in children and adolescents (Park, 2014).
 
A French study evaluating double unit transplants in adults with hematologic malignancies found an engraftment rate of 93% (127 of 136) and a median overall survival rate of 17.5 months (Wallet, 2013).
   
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Although cell doses are higher with double-unit transplants, studies published to date have found that survival rates are similar to transplants using single cord blood units and there is some suggestion of higher rates of GVHD. In 2014, Wagner and colleagues published a randomized controlled trial (RCT) comparing outcomes after double-unit (n=111) or single-unit (n=113) cord-blood transplants (Wagner, 2014).  The study included patients aged 1 to 21 years who had high-risk acute leukemia, chronic myeloid leukemia or myelodysplastic syndrome for whom there were 2 cord-blood units available with adequate cell doses and HLA matches on at least 4 of 6 loci. The primary outcome, 1-year overall survival rate, was 65% (95% confidence interval [CI], 56% to 74%) after double-unit transplant and 73% (95% CI, 63 to 80) after single-unit transplant. The difference between groups was not statistically significant (p=0.17). Similarly, 1-year disease-free survival was 64% (95% CI, 54% to 72%) in the double-unit transplant group and 70% (95% CI, 60% to 77%) in the single-unit transplant group (p=0.11). However, rates of acute grade II and IV GHVD was significantly higher in the double-unit transplant group (23%; 95% CI, 15% to 31%) than the single-unit transplant group (13%; 95% CI, 7% to 20%; p=0.02). The incidence of chronic GVHD after 1 year was similar in the 2 groups (32%; 95% CI, 23% to 40%, after double-unit transplant; and 30%, 95% CI, 22% to 29% after single-unit transplant; p=0.51). Results of a 2013 observational study were similar to those found in the Wagner RCT.
 
The evidence for cord blood as a source of stem cells in individuals undergoing allogeneic stem cell transplant includes a number of observational studies, a meta-analysis of observational studies, and   randomized controlled trial (RCT) comparing outcomes after single or double cord blood units. Relevant outcomes are overall survival, disease-specific survival, hospitalizations, resource utilization, and treatment-related mortality and morbidity. The meta-analysis of observational studies found similar survival outcomes and lower graft versus host disease after cord blood transplantation than bone marrow transplantation. In the RCT, survival rates were similar after single-unit and double-unit cord blood transplantation. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
 
The evidence for prophylactic collection and storage of cord blood from a neonate for individuals with an unspecified potential future need for stem cell transplant includes no published studies. Relevant outcomes include resource utilization. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
 
Ongoing:
(NCT01728545) The Collection and Storage of Umbilical Cord Blood for Transplantation; planned enrollment 250000; completion date June 2099.
 
(NCT00012545) Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease; planned enrollment 99,999,999; completion date, none provided.
 
American College of Obstetricians and Gynecologists
In 2015, the American College of Obstetricians and Gynecologists published a committee opinion on umbilical cord blood banking (Committee Opinion, 2015). The statement discussed counseling patients about options for umbilical cord blood banking, as well as benefits and limitations of this practice. Relevant recommendations include the following:
 
  • “Umbilical cord blood collection should not compromise obstetric or neonatal care or alter routine practice for the timing of umbilical cord clamping.”
  • “The current indications for cord blood transplant are limited to select genetic, hematologic, and malignant disorders.”
  •  “The routine storage of umbilical cord blood as “biologic insurance” against future disease is not recommended.
 
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Transplantation of 2 umbilical cord blood units (or double-unit transplants) has been evaluated as a strategy to overcome cell dose limitations with 1 cord blood unit in older and heavier patients. Initial experience at a university showed that using 2 units of cord blood for a single transplant in adults improved rates of engraftment and OS (Barker, 2005).
 
2018 Update
A literature search was conducted through July 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
38205Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic
38206Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous
38207Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage
88240Cryopreservation, freezing and storage of cells, each cell line
S2140Cord blood harvesting for transplantation, allogeneic
S2142Cord blood-derived stem-cell transplantation, allogeneic
S2150Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre and post transplant care in the global definition

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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