MT2022-01: MSCs for ALD (NCT06030648) | Clinical Trial Compass
SuspendedPhase 1
MT2022-01: MSCs for ALD
Stopped: Awaiting supplies
United States10 participantsStarted 2023-08-28
Plain-language 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), as a bridge to hematopoietic stem cell transplant or gene therapy, or in patients who are too advanced for gene therapy or HSCT. The intervention will occur in the time between diagnosis of active CALD and transplant which is currently 8-12 weeks.
Who can participate
Age range
3 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:
* 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 Criteria:
* 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.
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.
What they're measuring
1
Safety and tolerability of intravenously-administered allogeneic, third-party mesenchymal stem cells (IV-MSC).
Timeframe: 6 months
Trial details
NCT IDNCT06030648
SponsorMasonic Cancer Center, University of Minnesota