"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs (Hope Biosciences - Adipose Derived Mesenchymal Stem Cells) for the Treatment of Multiple System Atrophy."

April 14, 2026 updated by: Hope Biosciences Research Foundation

"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Multiple System Atrophy."

This expanded access protocol is part of IND 32226 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of Multiple System Atrophy for up to 7 adult patients who pass pre-screening and a completed screening. The subjects will receive 12 intravenous infusions of HB-adMSCs and 6 intrathecal injections of HB-adMSCs over the course of 44 weeks (1 infusion each month and 1 injection every other month).

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Sugar Land, Texas, United States, 77478
        • Available
        • Hope Biosciences Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Male and female participants 18-85 years of age
  2. Participants must have a diagnosis of "Clinically Established" or "Clinically Probable" MSA.
  3. Participants must have at least one brain MRI marker suggestive of MSA.
  4. Participants must have both autonomic failure and either poorly L-dopa-responsive parkinsonism or cerebellar ataxia.

  5. Female participants of childbearing potential should not be pregnant or plan to become pregnant during protocol participation and for 6 months after the last investigational product administration. Female participants of childbearing potential should confirm the use of one of the following contraceptive measures:

    • Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
    • Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
    • Barrier contraceptive methods (condoms, diaphragm, etc.).
    • Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).

    OR

    • Male participants if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during protocol participation and for 6 months after the last administration of the investigated product:
    • Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
    • Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
    • Barrier contraceptive methods (condoms, diaphragm, etc.).
    • Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).
  6. Participants should be able to read, understand, and to provide voluntary consent.

Exclusion Criteria:

  1. Women who are currently pregnant or lactating.
  2. The participant has any active infection requiring medications per PI's discretion.
  3. The participant has any clinical signs or symptoms of infection per PI's discretion.
  4. The participant has hyperthermia or hypothermia.
  5. The participant has any known recent (within the last 6 months) coagulation anomalies that are not being medically treated and are not stable per PI's discretion.
  6. The participant has any abnormal laboratory values at the screening visit which the Investigator determines to be clinically significant and make the patient unsuitable for participation.
  7. The Investigator determines the patient to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.
  8. The participant has a substantial and persistent response to dopaminergic medications.
  9. The participant has unexplained anosmia.
  10. The participant has fluctuating cognition, early dementia, or hallucinations.
  11. The participant has certain eye movement abnormalities.
  12. The participant has any MRI findings that suggest an alternative diagnosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hope Biosciences Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBMSA02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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