Status:
NO_LONGER_AVAILABLE
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Hope Biosciences Research Foundation
Conditions:
System; Lupus Erythematosus
Eligibility:
FEMALE
18-75 years
Brief Summary
This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and I...
Detailed Description
This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion
- Adult individual 18 years of age or older.
- Cognitively intact and capable of giving informed consent.
- Clinical diagnosis of Systemic Lupus Erythematosus.
- Subject has mesenchymal stem cells banked at Hope Biosciences.
- The patient accepts to receive treatment and to comply with follow-up visits.
Exclusion
- Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine diseases that in the opinion of the investigator may increase the risks associated with study participation.
- Active Alcohol or Drug addiction.
- Participation in concurrent interventional research studies during this study.
- Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
- 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
NCT04907175
Last Update
September 29 2025
Active Locations (1)
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1
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States, 77478