Status:
NO_LONGER_AVAILABLE
Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis
Lead Sponsor:
Hope Biosciences Research Foundation
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
Brief Summary
The drug for this submission is Hope Biosciences' autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Amyotrophic Lateral Scleros...
Detailed Description
Once the eligibility is confirmed, approximately 1-2 weeks after the screening visit, the subject will return for the baseline/first infusion visit. Subsequent treatments will occur 2 weeks apart for ...
Eligibility Criteria
Inclusion
- Documented diagnosis of Amyotrophic Lateral Sclerosis.
- Capable of giving informed consent (signed, verbal or assent as applicable and as listed in the protocol)
Exclusion
- Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
- Any abnormal, inexplicable laboratory result that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
- Participation in other interventional research studies within the past 30 days.
- Unwillingness to return for follow-up visits.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04514952
Last Update
September 29 2025
Active Locations (1)
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1
River Oaks Hospital and Clinics
Houston, Texas, United States, 77027