"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."

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18-85
SponsorHope Biosciences Research Foundation

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

No treatment groups listed