Cell production
BrainStorm has established production of autologous MSC-NTF cells at the scale and quality necessary to bring them to patients.
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Manufacturing
We have developed proprietary methods to engineer, produce and purify autologous MSC-NTF cells. Because the cells are the patient’s own, they are unlikely to induce an adverse immune response.
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Bone marrow is harvested and MSCs are isolated from the total bone marrow population
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MSCs are expanded ex-vivo and cryopreserved
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MSCs are thawed and induced to differentiate
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MSC-NTF cells are transplanted back into the patient by intrathecal administration
The full cycle: Bone Marrow Harvesting → Isolation → Expansion → Cryopreservation → Expansion → Differentiation → Intrathecal Transplantation.
100–125 × 10⁶
Cells per dose in the progressive MS trial
4 mL
Ready-for-injection syringe volume
Every 8 weeks
Repeat intrathecal administration schedule in the Phase 3b design
2 clean rooms
Academic GMP facilities supported Phase 3 production
Manufacturing partners
Dana-Farber Cancer Institute in Boston, Massachusetts and City of Hope National Medical Center in Duarte, California provided clean-room facilities for production of autologous MSC-NTF cells for the Phase 3 clinical trial in ALS.
Read next
BrainStorm's autologous MSC-NTF cell therapy (NurOwn®, debamestrocel) is investigational and has not been approved by the FDA or any other regulatory authority.