The observational study showed that use of cryopreserved hematopoietic stem cell grafts, did not impact patient overall survival compared to fresh grafts during the first year after transplant.
MINNEAPOLIS, MINN., April 18, 2023 – CIBMTR® (Center for International Blood and Marrow Transplant Research®) announced that the results of a multi-center observational study, around the impact of cryopreserved hematopoietic stem cell (HSC) grafts on patient survival rates were published in Blood Advances, a peer-reviewed open access medical journal published by the American Society of Hematology. The study showed that the shift in clinical practice to cryopreserved products necessitated during the pandemic did not adversely impact one-year overall survival. The CIBMTR is a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).
“The COVID-19 pandemic provided an unprecedented opportunity to study the impact of cryopreservation on clinical outcomes since the vast majority of patients received cryopreserved grafts for safety reasons at the onset of the pandemic. While it was comforting to find there were no differences in overall survival, there were more graft failures and relapses compared to fresh grafts”, said Steven Devine, MD, Chief Medical Officer, NMDP/Be The Match and Senior Scientific Director, CIBMTR NMDP. “These findings demonstrate that fresh grafts are preferred but that cryopreserved grafts do appear to be a good alternative during a crisis or if due to logistical reasons it could make the difference between transplant and no transplant.”
The COVID-19 pandemic necessitated a substantial increase in the use of cryopreserved HSC grafts from both related and unrelated donors to ensure patients had a graft available prior to the start of conditioning for HCT. This cryopreservation necessitation was due to increased logistical challenges from international travel bans and fluctuating donor availability due to unpredictable health. However, pre-pandemic data on the impact of cryopreservation on post-transplant outcomes was limited. At the onset of the pandemic, the CIBMTR rapidly completed three retrospective analyses of outcomes in recipients of cryopreserved compared to fresh grafts administered prior to the pandemic with varying results and in all cases lack of a unifying rationale for use of cryopreservation.
The NMDP mandated cryopreservation of their facilitated collections at that onset of the pandemic and many centers adopted a similar approach for locally collected products. Thus, early in the pandemic the vast majority of patients received planned cryopreserved allografts allowing CIBMTR to successfully evaluate early post-HCT clinical outcomes in patients reported to the CIBMTR database who received a first allogeneic HCT using cryopreserved grafts. The study subjects were US patients receiving fresh (March-August 2019) or cryopreserved (March-August 2020) bone marrow or peripheral blood stem cell transplants from matched related or unrelated donors. This study included 1,543 and 2,499 recipients of cryopreserved and fresh products, respectively.
The results demonstrated that the shift in clinical practice to cryopreserved products necessitated during the pandemic did not adversely impact one-year post-transplant overall survival, non-relapse mortality, acute graft-versus-host disease (GVHD), or GVHD-free, relapse-free survival in recipients of cryopreserved versus fresh allografts. However, the study did find an adverse impact of cryopreservation on disease-free survival due to a higher risk of relapse. There was also an increased risk of primary graft failure following cryopreservation. One advantage observed with cryopreserved grafts was a decreased risk of chronic GVHD consistent with results previously described in a single center study published by Dana Farber Cancer Institute. Based on these results the study team concluded that fresh grafts are recommended, and that cryopreservation should be considered an option for patients when infusion of fresh grafts are not feasible.
“NMDP/Be The Match and its research group CIBMTR are dedicated to providing clinical teams caring for HCT recipients with data that can inform their clinical practice, ensuring that patients thrive following transplant.,” said Amy Ronneberg, Chief Executive Officer, NMDP/ Be The Match. “We are proud to have taken leadership on this important graft study and to have the results shared broadly in Blood Advances.”
National Marrow Donor Program® (NMDP)/Be The Match®
The National Marrow Donor Program® (NMDP)/Be The Match® is the leading global partner working to save lives through cellular therapy. With 35 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, NMDP/Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy option—from blood stem cell transplant to a next-generation therapy—and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies®. NMDP/Be The Match is a tireless advocate for the cell therapy community, working with hematologists/oncologists to remove barriers to consultation and treatment, and supporting patients through no-cost programs to eliminate non-medical obstacles to cell therapy. In addition, they are a global leader in research through the CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a collaboration with Medical College of Wisconsin, investing in and managing research studies that improve patient outcomes and advance the future of care.
CIBMTR® (Center for International Blood and Marrow Transplant Research®)
Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the National Marrow Donor Program (NMDP)/ Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. The CIBMTR collaborates with the global scientific community to increase survival and enrich quality of life for patients. CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 630,000 people who have received hematopoietic cell transplantation and other cellular therapies. Learn more at cibmtr.org.
