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

System; Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04907175
• Other study ID #: HBSLE01
• Status: No longer available

Study information

• Verified date: May 2023
• Source: Hope Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• System; Lupus Erythematosus

Intervention

Biological:
• HB-adMSCs
Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.

Locations

Country	Name	City	State
United States	Hope Biosciences Stem Cell Research Foundation	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Hope Biosciences Stem Cell Research Foundation	Hope Biosciences

Country where clinical trial is conducted

United States,