Status:
SUSPENDED
MT2022-01: MSCs for ALD
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Cerebral Adrenoleukodystrophy
Eligibility:
All Genders
3+ years
Phase:
PHASE1
Brief Summary
This is a single-institution study to evaluate the use of intravenously administered allogeneic, 3rd party mesenchymal stem cells (IV-MSC) in patients with active, cerebral adrenoleukodystrophy (CALD)...
Eligibility Criteria
Inclusion
- age ≥ 3 years
- diagnosis of ALD, as established by elevation of very long chain fatty acid levels or gene mutation
- evidence of active cerebral disease as determined by the presence of gadolinium enhancement
- ALD MRI (Loes) score ≥ 1
- Patients who have not received prior gene therapy or transplant
- Life expectancy of \> 6 months as determined by the enrolling researcher
- Have adequate organ function confirmed by laboratory values obtained within 28 days prior to enrollment
Exclusion
- Inability to undergo sedation or MRI studies for any reason
- Other concurrent life-threatening disease (life expectancy \<6 months) or eligible for hospice care
- Known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06030648
Start Date
August 28 2023
End Date
May 1 2028
Last Update
May 30 2025
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455