0000819789 00000 n In May 2020, Gamida Cell announced preliminary results of their phase 3 trial of stem cell transplants with the expanded cord blood product Omidubicel (formerly known as NiCord®) 1. Find all our resources on COVID-19 here and filter by your area of interest. 0000710185 00000 n 0000673409 00000 n 0000785812 00000 n
0000819672 00000 n Omidubicel is an advanced cellular therapy being developed as a bone marrow transplant product.
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The primary endpoint measure was the cumulative incidence of pts with NiCord®-derived neutrophil engraftment at 42 days following transplantation. 0000332651 00000 n 0000718131 00000 n 0000005081 00000 n 0000751991 00000 n NiCord treatment was associated with a significant reduction in the rate and severity of infections as well as significantly shorter hospital stays.
0000332800 00000 n 0000420879 00000 n Omidubicel is a stem cell therapy composed of umbilical cord-derived ex vivo expanded stem and progenitor cells, being developed by Gamida Cell, as an infusion Omidubicel - Gamida Cell - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript. 0000669624 00000 n 0000697373 00000 n Omidubicel is a product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood; it is intended to increase migration, bone marrow homing, and engraftment of … June 2020. 0000002044 00000 n 0000682676 00000 n 0000251351 00000 n 0000005195 00000 n 0000332926 00000 n %PDF-1.4 %���� 0000708209 00000 n 0000087300 00000 n 0000336695 00000 n In a PI/II single-arm, open-label trial study (NCT01816230; EudraCT2014-000074-19), 43 adult pts with high-risk haematological malignancies in the US, Italy, the Netherlands, Singapore and Spain undergoing transplantation with a single unit of NiCord had rapid and long-lasting engraftment of neutrophils and platelets vs. pts who received cord blood alone. Frances Verter, PhD. 0000333583 00000 n Approval and commercialisation of omidubicel may be in collaboration with strategic partners, particularly in Europe.
0000001656 00000 n To work properly, this page requires JavaScript to be enabled. Omidubicel from Gamida Cell leads the way to Cord Blood Transplant version 2.0.
It consists of ex vivo expanded allogeneic cells from one unit of umbilical cord blood. 0000586703 00000 n 0000710548 00000 n 0000002382 00000 n trailer <<11FA444A5CBE418B923141972C36DA7F>]/Prev 1074478/XRefStm 2044>> startxref 0 %%EOF 278 0 obj <>stream 0000334959 00000 n 0000335822 00000 n
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0000337094 00000 n 0000335459 00000 n 0000334283 00000 n Gamida presented positive results at the 52nd Annual Meeting of the American Society of Clinical Oncology showing improved engraftment, reduced morbidity and less transplant related mortality compared to controls.
0000691426 00000 n In its latest annual report, Gamida Cell states that it plans to seek regulatory approval for omidubicel in the US and EU. 0000683238 00000 n 0000335046 00000 n View current examples or submit your work. 0000700912 00000 n 0000682971 00000 n 0000002223 00000 n 0000332248 00000 n 0000003862 00000 n 0000333445 00000 n 0000717795 00000 n 0000333836 00000 n 0000819711 00000 n 0000697478 00000 n 0000708321 00000 n 0000697654 00000 n
0000000016 00000 n A single cord blood unit expanded into Omidubicel provided transplant patients with neutrophil engraftment in a median of 12 days 1,2.
[1-4] 0000697706 00000 n Our resource hub supports pharmacy teams in care homes who are responding to increased pressure during the COVID-19 pandemicOur repository of good practice supports the WHO Medication Without Harm Global Patient Safety challenge.
0000003376 00000 n 0000004404 00000 n No timeline is given for EU approval (unlike for US approval) [11]. h�b``a``?�����+Ć�;����&0���3�2�X8�M`�� 211 0 obj <> endobj xref 0000717544 00000 n 0000333348 00000 n 0000334543 00000 n Omidubicel: An investigational advanced cell therapy designed to enhance the life-saving benefits of bone marrow transplant O midubicel, Gamida Cell’s lead investigational product candidate, is an advanced cellular therapy in Phase 3 development as a potential life-saving allogeneic
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