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."
Brief Summary

This expanded access protocol is part of IND 32226 to evaluate efficacy and safety ofmultiple intravenous administrations of allogeneic HB-adMSCs for the treatment ofMultiple System Atrophy for up to 7 adult patients who pass pre-screening and a completedscreening. The subjects will receive 12 intravenous infusions of HB-adMSCs and 6intrathecal injections of HB-adMSCs over the course of 44 weeks (1 infusion each monthand 1 injection every other month).

Detailed Description

Not Provided

Temporarily not available
Intermediate-size Population
Multiple System Atrophy

Biological: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells

Intravenous and intrathecal infusion of Hope Biosciences autologous adipose-derived stem
cells

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
United States
Locations

Hope Biosciences Research Foundation
Sugar Land 4734825, Texas 4736286, United States

Not Provided

Hope Biosciences Research Foundation
NCT Number
Keywords
MSA
stem cells
MSCs
MeSH Terms
Multiple System Atrophy
Thyroid Dyshormonogenesis 2A