Current clinical data suggests that patients treated with Gamida Cell’s omidubicelThis website supports the following studies conducted by Gamida Cell:Gamida Cell conducted a Phase III clinical study of omidubicel (NiCord®). standard umbilical cord blood. –Median CD34+ cell dose 3.5 x 106/kg in Nicord vs. 0.07 x 106/kg in unmanipulated unit • Neutrophil recovery median 13 days • Engraftment: –8 patients with complete or partial myeloid and T cell engraftment from NiCord unit –2 patients with engraftment from unmanipulated unit –1 patient with engraftment failure Horwitz et al J Clin Invest 2014. NiCord also demonstrated an acceptable
safety profile for patients undergoing bone marrow transplant.
reduction in their time to neutrophil and platelet recovery compared to Moreover, the available data shows that patients treated with omidubicel are able to develop functional hematopoietic systems, with the development of myeloid and lymphoid cells, supporting immune recovery.
accessible to patients with lethal blood cancers.” “These data suggest
NiCord compared to a retrospective cohort of patients who received The platform technology, called NAM technology, was developed by Gamida Cell scientists and is a proprietary asset of the Company. estimated that more than 40 percent of eligible patients do not receive
However, its use is limited by delayed hematopoietic recovery, leading to increased morbidity and mortality post transplantation. completing patient enrollment expected in the second half of 2019.” Shares of Gamida Cell (NASDAQ:GMDA) moved higher by 1.6% in pre-market trading after the company reported Q2 results.
2. professor of medicine at the Duke Cancer Institute. resulted in fewer days spent in the hospital compared to the comparator Gamida Cell is a world leader in expansion of stem cell therapy products for transplantation and regenerative medicine.
using a matched donor source,” stated Ronit Simantov, M.D., chief
Note: NiCord® is further being developed as a standalone graft for SCD and other rare genetic diseases, and has subsequently been branded and listed on the Gamida Cell website as “CordIn™”. a retrospective cohort of patients who received a standard umbilical Gamida Cell president and CEO Dr. Yael Margolin said, “These data, in addition to the top line data from the Phase 1/2 study released in December 2015, define the potential clinical benefit of using NiCord as a graft source.
NiCord had rapid and durable engraftment of neutrophils and platelets, We hope to further confirm these findings and establish the clinical benefit of NiCord in the upcoming randomized controlled Phase 3 registration study. “These data demonstrate the potential of NiCord to give patients with who would otherwise not be able to receive a bone marrow transplant The neutrophil recovery observed with NiCord also
This website provides access for participating clinical sites, collaborating CROs, and the sponsor to obtain information relevant to the trial.
high-risk blood cancers an opportunity for a cure, particularly patients
“In this study, patients who received NiCord had a clinically meaningful About NiCord NiCord, Gamida Cell’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company. Gamida Cell announced the publication of data from the previously reported, Phase 1/2 NiCord study in the Journal of Clinical Oncology. medical officer at Gamida Cell. recovery was shortened by nearly 50 percent for patients who received We look forward to
“We are actively enrolling patients in
to be an effective transplantation solution. Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation..
The median time to neutrophil NiCord … cord blood transplant.
The chief aim of the study (Gamida Cell is initiating an open label access study for the omidubicel product. cohort,” said Mitchell Horwitz, M.D., principal investigator and