System; Lupus Erythematosus
Conditions
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 International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.
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).
Interventions
BIOLOGICALHB-adMSCs
Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.
Sponsors
Hope Biosciences Research Foundation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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.
Countries
United States
Outcome results
None listed