Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

N/ANo Longer AvailableNCT04907175

Hope Biosciences Research Foundation

Overview

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.

This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).

Study Type

EXPANDED_ACCESS

Conditions

System; Lupus Erythematosus

Interventions

HB-adMSCsBIOLOGICAL

Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, United States

Data from ClinicalTrials.gov

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