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Stem cell hope for rare brain disease: new expanded access trial opens

NCT ID NCT07238062

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study offers expanded access to an experimental stem cell treatment for up to 7 adults with Multiple System Atrophy (MSA), a rare and serious brain disorder. Participants will receive 12 intravenous infusions and 6 spinal injections of donor stem cells over 44 weeks. The goal is to evaluate safety and whether the treatment can help control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hope Biosciences Research Foundation

    AVAILABLE

    Sugar Land, Texas, 77478, United States

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