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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells | Biological | Intravenous and intrathecal infusion of Hope Biosciences allogeneic adipose-derived stem cells |
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:
OR
Participants should be able to read, understand, and to provide voluntary consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Gonzalez, RN | Contact | 346-900-0340 | 101 | david@hopebio.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Research Foundation | Available | Sugar Land | Texas | 77478 | United States |
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| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| C563206 | Thyroid Dyshormonogenesis 2A |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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