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

Conditions
System; Lupus Erythematosus
Registration Number
NCT04907175
Lead Sponsor
Hope Biosciences Stem Cell Research Foundation
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).

Recruitment & Eligibility

Status
NO_LONGER_AVAILABLE
Sex
Female
Target Recruitment
Not specified
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.
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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.
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Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hope Biosciences Stem Cell Research Foundation

🇺🇸

Sugar Land, Texas, United States

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