AVAILABLENot Applicable

"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."

United States

Plain-language 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).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. Participants should be able to read, understand, and to provide voluntary consent.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT07238062

SponsorHope Biosciences Research Foundation

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

David Gonzalez, RN

346-900-0340 david@hopebio.org

View on ClinicalTrials.gov More Multiple System Atrophy trials