Tag Archive for: allogeneic transplant

Omidubicel (Expanded Cord Blood) for use in Allogeneic Transplant


Umbilical Cord Blood (UCB) has been used as a source of stem cells in allogeneic (donor) transplants since the late 1980s. When doing a transplant using bone marrow (BM) or peripheral blood (PB), it is necessary to have a close Human Leukocyte Antigen (HL) type match to reduce the chance of the transplant being rejected and the risk of Graft-Versus-Host Disease (GVHD). Since UCB contains more naïve cells, it does not need to match nearly as well to be used as a source of stem cells in a transplant. This is important for people who do not have good unrelated donor matches in the registries, in particular minorities who tend to be underrepresented in the registries and people of mixed race.

Since a single UCB unit contains significantly fewer stem cells than a PB or BM graft, it takes longer for a patient’s white blood (neutrophil) count and platelet count to recover when getting a UCB transplant. This is a fundamental problem of using UCB for transplants. This means that patients are at risk of infections for a longer time. There have been a number of attempts to expand the number of cells in a cord blood unit, dating back at least 20 years, but none have managed to be approved by the U.S. Food and Drug Administration (FDA).

FDA Approval

The FDA approved omidubicel to reduce time to neutrophil recovery in April, 2023. This was based on a Phase 3 randomized study (reported in Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study) that compared the outcome of patients who received omidubicel versus those who underwent conventional cord blood transplants.

Comparison of Omidubicel and standard Cord Blood transplants

The trial enrolled 125 patients who were randomly assigned to receive omidubicel (62 patients) or a standard UCB transplant (63). Patients in the standard transplant arm received a double cord transplant if the initial CB unit was not well matched or contained a smaller number of cells. 67% of those patients received a double cord transplant, 33% a single cord transplant. Three alternative myeloablative conditioning regimens were allowed and different regimens to prevent GVHD.

The time to white blood cell recovery (a neutrophils count of at least 500) and platelet recovery (a count of at least 20) was much faster in patients who received omidubicel. Patients who received omidubicel had neutrophil recovery a median of 10 days faster than patients who received a standard UCB. Platelet recovery was a median of 13 days faster for those receiving omidubicel. Patients who received omidubicel spent a median of 11 fewer days in the hospital in the first 100 days post-transplant and experienced fewer serious infections..

There are a couple of drawbacks to omidubicel. About 10% of the CB units had manufacturing or production failure. In addition, it takes about 21 days to manufacture omidubicel. These issues resulted 14% of patients not being able to receive the therapy.


Omidubicel is a significant advance in the use of cord blood for transplants. There was a big reduction in hospital stays and infections. There may be a survival benefit with omidubicel., the study was too small to determine if there was a statistically significant increase in survival, although there seemed to be a trend toward better survival. The authors of the paper in Blood , state: “The results suggest that omidubicel may be considered as a new standard of care for adult patients eligible for UCBT”. I think this probably is an understatement and centers that use cord blood in adults and older children will rapidly start using omidubicel. No doubt there will be a high price for omidubicel, but this is likely to be balanced out by reduced number of days in the hospital.

A major question that remains unanswered is how omidubicel will now compare to transplants using an unrelated donor or a half-matched family member (haploidentical). My guess is that most centers that do not do cord blood transplants in adults will continue to use unrelated or haploidentical donors. Probably, in a few years there will be a comparison done, at least using data from transplant registries.

I asked Karen Ballen, M.D. Chief, Hematology/Oncology, University of Virginia Cancer Center for comment on omidubicel (I would also like to thank her for graciously providing comments on this article):

Omidubicel is the first product approved by the FDA for expansion of a stem cell transplant graft, in this case cord blood. The randomized clinical trial showed an advantage in neutrophil and platelet engraftment and days in the hospital. There was no survival benefit, which could potentially limit use. The cost of the product is unknown. Another drawback is the 2.5 to 3 weeks needed to manufacture. Nonetheless, this represents a major advance in the cell therapy field.

Further Reading

Is Stem Cell Transplantation Still a Treatment Option for Some DLBCL Patients?

Is Stem Cell Transplantation Still a Treatment Option for Some DLBCL Patients? from Patient Empowerment Network on Vimeo.

Can diffuse large B-cell lymphoma (DLBCL) patients expect to undergo stem cell transplant? Expert Dr. Nirav Shah from the Medical College of Wisconsin explains some alternatives to stem cell transplant in specific situations and shares his perspective about how the use of stem cell transplants may evolve in the future. 

Dr. Nirav Shah is an Associate Professor at the Medical College of Wisconsin. Learn more about Dr. Shah.


“…don’t discard transplantation because it’s an older therapy, it’s just one that needs to be used in the right scenario for each patient.”


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Related Resources:

What Promising Treatments Are Available for Diffuse Large B-Cell Lymphoma Patients

What Promising Treatments Are Available for Diffuse Large B-Cell Lymphoma Patients

When Should CAR-T Therapy Be Considered for Relapsed_Refractory DLBCL Patients

When Should CAR-T Therapy Be Considered for Relapsed/Refractory DLBCL Patients

How Can Diffuse Large B-Cell Lymphoma Treatment Symptoms Be Managed

How Can Diffuse Large B-Cell Lymphoma Treatment Symptoms Be Managed


Lisa Hatfield:  

So in light of all of these newer therapies, there’s still a place for stem cell transplantation with the DLBCL patients? 

Dr. Nirav N. Shah:

Yeah, great question. So the goal is always to do better. And so we have this new exciting therapy called CAR T, that for a lot of patients is going to replace the role of the stem cell transplant. However, there still is a role for transplant in patients that have later relapse, so those patients who relapse one to two years, transplant is still a standard of care and an option that I would consider for my patients, and there’s more than one type of stem cell transplant out there. So we often think about autologous transplants in diffuse large B-cell lymphoma, where we use our own immune system to rebuild it after giving a high intensity chemotherapy treatment to eliminate the cancer. But there’s a second type of transplant called allogeneic stem cell transplant, and that is where we actually replace your whole immune system with one from a healthy donor.

Our group, actually, for patients that fail CAR T-cell therapy, which is one of our better treatment options that we have, but again, not 100 percent effective, we’ve used allogeneic stem cell transplant to try and cure those patients and offer them something where we replace their immune system with one from a healthy donor to be able to get rid of the cancer where other treatments have failed.

So I think that how we use transplant is going to be redefined with newer therapies and immune therapies like CAR , immune T or bispecific antibodies. But I do think that either auto or allogeneic transplant is still going to be part of the treatment algorithms, especially for those patients who have failed other options. So my activation point is don’t discard transplantation because it’s an older therapy, it’s just one that needs to be used in the right scenario for each patient. 

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