Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
NCT04907175 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-09-29
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 International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.
Conditions
- System; Lupus Erythematosus
Interventions
- BIOLOGICAL
-
HB-adMSCs
Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.
Sponsors & Collaborators
-
Hope Biosciences Research Foundation
lead INDUSTRY
Principal Investigators
-
Thanh Cheng, MD · Hope Biosciences Stem Cell Research Foundation
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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