System; Lupus ErythematosusNCT04907175
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
A study testing HB-adMSCs in people with System; Lupus Erythematosus, run by Hope Biosciences Research Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- System; Lupus Erythematosus
- What is being tested?
- HB-adMSCs
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, 77478
About this study
Official title: Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
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.
Read the 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).
- Conditions
- System; Lupus Erythematosus
- Being tested
- HB-adMSCs
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCsBiological
Also called MSC's
Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System; Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thanh Cheng, MD, Principal investigator, Hope Biosciences Stem Cell Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907175
- Sponsor's protocol ID
- HBSLE01
- Status last verified
- Sep 2025
- First submitted
- 26 May 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT04907175
- Acronym / sponsor ID
- HBSLE01
- Conditions
- System; Lupus Erythematosus
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-adMSCsAlso: MSC'sSubject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh Cheng, MD principal investigator
Hope Biosciences Stem Cell Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB-adMSCs in people with System; Lupus Erythematosus, run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.