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

Primary Purpose

System; Lupus Erythematosus

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
HB-adMSCs
Sponsored by
Hope Biosciences Stem Cell Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for System; Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Female

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.

Sites / Locations

  • Hope Biosciences Stem Cell Research Foundation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 26, 2021
Last Updated
May 2, 2023
Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04907175
Brief Title
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
Official Title
Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
Study Type
Expanded Access

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
System; Lupus Erythematosus

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HB-adMSCs
Other Intervention Name(s)
MSC's
Intervention Description
Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanh Cheng, MD
Organizational Affiliation
Hope Biosciences Stem Cell Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Biosciences Stem Cell Research Foundation
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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