ClinicalTrials.gg
AvailableNCT07238062Updated Apr 17, 2026

"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."

An expanded access record providing HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells in Multiple System Atrophy, sponsored by Hope Biosciences Research Foundation. Available at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Hope Biosciences Research Foundation · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Multiple System Atrophy

Keywords

  • msa
  • stem cells
  • MSCs
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

Browse Multiple System Atrophy studies →

Lead sponsor

Hope Biosciences Research Foundation is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • BiologicalHB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells

    Intravenous and intrathecal infusion of Hope Biosciences allogeneic adipose-derived stem cells

06

Where to request access

1 of 1 sites recruiting
  • Hope Biosciences Research Foundation
    Sugar Land, Texas 77478, United States
    Available
    • Djamchid Lotfi, MD · Principal investigator
    • Thanh Cheng, MD · Sub investigator
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT07238062
Responsible party
Sponsor
First posted
Nov 20, 2025
Last update
Apr 17, 2026

Study contacts

David Gonzalez, RN
Contact
david@hopebio.org
346-900-0340 ext. 101
View the source record on ClinicalTrials.gov ↗

Requesting access

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