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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2023
  • participants needed
    6
  • sponsor
    Rohto Pharmaceutical Co., Ltd.
Updated on 27 September 2021

Summary

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

Description

This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration.

Details
Condition Cerebral Palsy (Pediatric), Periventricular leukomalacia, cerebral palsy (cp), Cerebral Palsy
Treatment UDI-001
Clinical Study IdentifierNCT04873752
SponsorRohto Pharmaceutical Co., Ltd.
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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