Welcome to the Gamida Cell Omidubicel Studies Coordinating Center
Gamida Cell strives to enable patients with blood cancers and other serious diseases to achieve cures through next-generation cell therapies. Unmanipulated cord blood is an easily procured stem cell source for allogeneic hematopoietic stem cell transplants, with high availability for patients of different ethnic backgrounds. However, its use is limited by delayed hematopoietic and immune cell recovery, leading to increased morbidity and mortality post transplantation. Current clinical data suggests that patients treated with Gamida Cell’s omidubicel1 (formerly NiCord®) can rapidly engraft both neutrophils and platelets. Moreover, the available data shows that patients treated with omidubicel are able to develop functional hematopoietic systems, together with the reconstitution of myeloid and lymphoid cells, supporting a robust and long-term immune recovery.2,3
This website supports the following studies conducted by Gamida Cell:
- Gamida Cell conducted a Phase III clinical study of omidubicel entitled (GC P# 05.01.020: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies). The study compared, the safety and efficacy of omidubicel ex vivo expanded single cord blood unit transplantation versus single or double unmanipulated cord blood unit (UCBU) transplantation following myeloablative conditioning therapy. Recruitment for this study completed at the end of 2019. A five-year long-term follow-up study is continuing for enrolled patients.
The study was conducted at more than 50 centers in the U.S., Europe, Latin America, and Asia, and included 125 patients aged 12–65 years with Hematological Malignancies. Gamida Cell has completed one year follow-up analysis of the study and the results of the intent-to-treat analysis demonstrated the median time to neutrophil engraftment was significantly shorter in patients randomized to omidubicel than in the control group (12 vs 22 days, p <0.001). Among patients who were transplanted per protocol, 96% of patients who received omidubicel achieved successful neutrophil engraftment, compared to 89% of patients transplanted with UCBU. Further analyses of secondary endpoints demonstrated statistically significant platelet engraftment, less grade 2-3 bacterial and fungal infections and less days in hospital for the omidubicel patients3.
- Gamida Cell also initiated an open label access study for the omidubicel product entitled GC P#07.01.020 An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients with Hematological Malignancies. This study will primarily continue to provide access of omidubicel for patients with Hematological Malignancies and to collect additional safety and efficacy data. The study will enroll patients from 12 years of age in clinical centers across the U.S.
If you are a patient, caregiver or physician who is interested in learning more about the study, please contact Gamida Cell at medicalinformation@gamida-cell.com or visit www.clinicaltrials.gov (NCT04260698).
The Gamida Cell Studies Coordinating Center website is password-protected and contains information related to the Gamida Cell omidubicel protocols being managed by The Emmes Company, LLC. This website provides access for participating clinical sites, collaborating CROs, and the sponsor to obtain information relevant to the trial. For authorized individuals, this website provides access to the study protocols, sponsor SOPs, data entry user guides and instructions, site startup and regulatory documents, reports, and other relevant materials needed for the conduct of the trial.
Access to this web site is restricted. If you need access, please contact Gamida Cell Data Coordinating Center by sending an email to gamidadcc@emmes.com.
1 Gamida Cell’s lead development candidate, omidubicel, (expanded CD34+ hematopoietic stem cells) and differentiated immune cells, including T cells. Gamida Cell refers to the two components (fractions) collectively as “omidubicel.”
2 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.
3 Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440.