Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Spinal Cord Injury

Status:

NO_LONGER_AVAILABLE

Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Spinal Cord Injury

Lead Sponsor:

Hope Biosciences Research Foundation

Conditions:

Spinal Cord Injuries

Eligibility:

All Genders

18+ years

Brief Summary

HBSCI02: This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about 4:30pm, slippe...

Detailed Description

HBSCI02: Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline visit, the subject will receive the first infusion. Subsequent treatments will occur every other week ...

Eligibility Criteria

Inclusion

HBSCI02:
Adult individual 18 yr. of age or older.
Cognitively intact and capable of giving informed consent.
Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine
Patient and Caregiver agree to use Care Connect app or web version of VirTrial platform for virtual visits.

Exclusion

Prior history of:
Recent or ongoing infection,
Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease,
Neurodegenerative disorders,
Cancer,
Immunosuppression as defined by WBC \< 3, 000 cells/ml at baseline screening,
Chemical or ETOH dependency,
Having a contraindication to MRI scans
Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
Participation in other interventional research studies.
Unwillingness to return for follow-up visits
HBSCI04:
Inclusion Criteria:
Adult individual 18 years of age or older.
Cognitively intact and capable of giving informed consent.
Clinical diagnosis of Spinal Cord Injury.
Subject has mesenchymal stem cells banked at Hope Biosciences.
The patient accepts to receive treatment and to comply with follow-up visits.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04064957

Last Update

September 29 2025

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