Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy
NCT04029896 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-09-29
Summary
This is an Individual Patient Expanded Access Protocol of Autologous HB-adMSCs for the Treatment of Cerebral Palsy (CP) with the primary goal of treating 1 individual with CP who has exhausted all treatment options, his condition has not improved, his quality of life is severely affected by the condition and he has previously banked his mesenchymal stem cells. There are no FDA approved, fully restorative treatments for CP. The subject will receive 8 autologous HB-adMSC infusions of 50 million (50 x 10\^6 cells) total cells. A protocol amendment to administer additional HB-adMSC infusions may be submitted for IRB/FDA for approval depending on the patient's response, AE/SAEs, and cell expansion characteristics.
Conditions
- Cerebral Palsy
Interventions
- BIOLOGICAL
-
HB-adMSCs
intravenous infusion of Hope Biosciences autologous adipose-derived stem cells
Sponsors & Collaborators
-
Hope Biosciences Research Foundation
lead INDUSTRY
Eligibility
- Min Age
- 3 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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