CompletedPhase 1/2

A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy

Japan6 participantsStarted 2021-06-02

Plain-language summary

UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.

Who can participate

Age range

12 Months – 24 Months

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 \>= 12 months and \< 24 months corrected age at the time of informed consent * Diagnosed with cerebral palsy * Diagnosed with PVL * GMFCS level between II and IV * Able to obtain written informed consent from parents (legal representative) Exclusion Criteria: * Presence of progressive neurological disease * Presence of congenital anomaly * Diagnosed with Grade 3 or more severe intraventricular hemorrhage * Body weight \< 5kg * Profound intellectual disorder * Complication of serious infection such as sepsis * Requirement of mechanical ventilation * Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate * Diagnosed with or suspected of hypsarrhythmia * Positive for HBV, HCV, HIV or HTLV-1 * Patients who have received cell therapy * Patients who have undergone selective dorsal rhizotomy or received botulinum toxin products within a certain period of time

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

Safety: Adverse Event

Timeframe: until Week 52

Trial details

NCT IDNCT04873752

SponsorRohto Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-12

View on ClinicalTrials.gov More Cerebral Palsy trials

Who can participate

Age range

12 Months – 24 Months

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.