Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy (NCT07763028) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy
Indonesia7 participantsStarted 2024-12-01
Plain-language summary
This is a single-center, open-label, single-arm Phase I pilot study designed to evaluate the feasibility and short-term safety of a single intrathecal administration of allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) in children with cerebral palsy (CP).
Who can participate
Age range
2 Years – 5 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:
* Children aged 2-5 years. Diagnosis of cerebral palsy, independently confirmed by two experienced pediatric neurologists.
Gross Motor Function Classification System (GMFCS) level II-V. Parent(s) or legal guardian(s) able and willing to provide written informed consent.
Exclusion Criteria:
* History of congenital infection, including toxoplasmosis, rubella, cytomegalovirus, herpes simplex virus, or other clinically relevant congenital infections.
Normal findings on brain neuroimaging. Known malignancy. Confirmed genetic or congenital disorder unrelated to cerebral palsy. Advanced systemic disease, including renal insufficiency, hepatic dysfunction, or severe anemia.
Previous treatment with stem cell or stromal cell therapy. Participation in another interventional clinical study.
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
Number of Participants Who Successfully Completed Intrathecal Administration of the Intended UCT-MSC Dose Without Technical Failure and Completed the 6-Month Follow-up
Timeframe: From the intrathecal administration through 6 months after intervention.
2
Number of Participants With Treatment-Emergent Adverse Events Following Intrathecal Administration of Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells
Timeframe: From the intrathecal administration through 6 months after intervention.