Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

HBSLE01

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.

-1

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}

2023-05-06