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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)

NCT05203419

Lupus Erythematosus, Systemic

TERMINATED PHASE1

Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study

NCT00271934

Systemic Lupus Erythematosus

COMPLETED PHASE2

Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells

NCT07041801

Systemic Lupus Erythematosus (SLE)

RECRUITING PHASE1/PHASE2

A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus

NCT07299422

Systemic Lupus Erythematosus

NOT_YET_RECRUITING PHASE2

Autologous Stem Cell Transplantation: International Lupus Trial

NCT05063513

REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS

WITHDRAWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

System; Lupus Erythematosus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HB-adMSCs

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MSC's

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No