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

NCT04907175 | Unknown

• 1 other identifier: HBSLE01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

System; Lupus Erythematosus

Interventions

HB-adMSCs BIOLOGICAL

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

Also known as: MSC's

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thanh Cheng, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)