Multiple System AtrophyNCT07238062
"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."
A study testing HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells in people with Multiple System Atrophy, run by Hope Biosciences Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
- 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 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male and female participants 18-85 years of age
- Participants must have a diagnosis of "Clinically Established" or "Clinically Probable" MSA.
- Participants must have at least one brain MRI marker suggestive of MSA.
- Participants must have both autonomic failure and either poorly L-dopa-responsive parkinsonism or cerebellar ataxia.
- 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).
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- 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)).
- Participants should be able to read, understand, and to provide voluntary consent.
Who cannot join
- Women who are currently pregnant or lactating.
- The participant has any active infection requiring medications per PI's discretion.
- The participant has any clinical signs or symptoms of infection per PI's discretion.
- The participant has hyperthermia or hypothermia.
- 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.
- 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.
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- 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.
- The participant has a substantial and persistent response to dopaminergic medications.
- The participant has unexplained anosmia.
- The participant has fluctuating cognition, early dementia, or hallucinations.
- The participant has certain eye movement abnormalities.
- The participant has any MRI findings that suggest an alternative diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Hope Biosciences Research Foundation
Sugar Land, Texas, 77478
Djamchid Lotfi, MD
Thanh Cheng, MD
About this study
Official title: "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).
- Conditions
- Multiple System Atrophy
- Being tested
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
- Keywords
- msa, stem cells, MSCs
- Medical subject headings
- Multiple System Atrophy, Thyroid Dyshormonogenesis 2A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem CellsBiological
Intravenous and intrathecal infusion of Hope Biosciences allogeneic adipose-derived stem cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238062
- Sponsor's protocol ID
- HBMSA02
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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."
- ClinicalTrials.gov ID
- NCT07238062
- Acronym / sponsor ID
- HBMSA02
- Conditions
- Multiple System Atrophy
- Keywords
- msa, stem cells, MSCs
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 20 Nov 2025 (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 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 design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female participants 18-85 years of age
- Participants must have a diagnosis of "Clinically Established" or "Clinically Probable" MSA.
- Participants must have at least one brain MRI marker suggestive of MSA.
- Participants must have both autonomic failure and either poorly L-dopa-responsive parkinsonism or cerebellar ataxia.
- 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:
Key exclusion criteria (12 listed)
- Women who are currently pregnant or lactating.
- The participant has any active infection requiring medications per PI's discretion.
- The participant has any clinical signs or symptoms of infection per PI's discretion.
- The participant has hyperthermia or hypothermia.
- 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.
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-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem CellsIntravenous and intrathecal infusion of Hope Biosciences allogeneic adipose-derived stem cells | 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 17 Apr 2026.
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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.
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 - Hope Biosciences Adipose Derived Mesenchymal Stem Cells in people with Multiple System Atrophy, 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 16 inclusion and 12 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 17 Apr 2026. 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?
Contact David Gonzalez, RN (346-900-0340 ext. 101, david@hopebio.org), or a site near the patient. 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 17 Apr 2026.