Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy

NCT07763028 | Active Not Recruiting Phase 1

• 1 other identifier: KE/FK/1919/EC/2024
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral palsy; clinical trial; stromal cell; intrathecal; outcome; adverse event; safety

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Successfully Completed Intrathecal Administration of the Intended UCT-MSC Dose Without Technical Failure and Completed the 6-Month Follow-up

  Feasibility was defined as successful delivery of the intended dose of allogeneic umbilical cord-derived mesenchymal stromal cells (UCT-MSCs), completion of the intrathecal administration without technical failure, completion of the planned post-procedural observation, participant retention through the 6-month follow-up, and absence of protocol deviations preventing completion of the intervention or follow-up.

  From the intrathecal administration through 6 months after intervention.

• Number of Participants With Treatment-Emergent Adverse Events Following Intrathecal Administration of Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells

  Safety was assessed by recording immediate and delayed treatment-emergent adverse events occurring during the procedure, during hospitalization, and throughout the 6-month follow-up period. Events of interest included fever, vomiting, headache, irritability, back pain, local procedural complications, infection, allergic or infusion-related reactions, seizure, altered consciousness, neurological deterioration, prolonged hospitalization, and serious adverse events. For each adverse event, the time of onset, maximum severity, duration, management, clinical outcome, seriousness, and investigator-assessed relationship to the intervention were documented.

  From the intrathecal administration through 6 months after intervention.

Secondary Outcomes (5)

• Gross Motor Function Classification System (GMFCS) Level

  Baseline, Month 1, Month 3, and Month 6

• Manual Ability Classification System (MACS) Level

  Baseline, Month 1, Month 3, and Month 6

• Communication Function Classification System (CFCS) Level

  Baseline, Month 1, Month 3, and Month 6

• Eating and Drinking Ability Classification System (EDACS) Level

  Baseline, Month 1, Month 3, and Month 6

• Modified Ashworth Scale (MAS) Score

  Baseline, Month 1, Month 3, and Month 6

Study Arms (1)

Intrathecal UCT-MSC

EXPERIMENTAL

Participants receive a single intrathecal administration of allogeneic umbilical cord-derived mesenchymal stromal cells 2 × 10⁶ viable UCT-MSCs/kg body weight administered by lumbal puncture.

Biological: allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)

Interventions

allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) BIOLOGICAL

A single intrathecal dose of allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) at 2 × 10⁶ viable cells/kg body weight

Intrathecal UCT-MSC

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Dr. Sardjito Hospital

Yogyakarta, D.I. Yogyakarta, 55284, Indonesia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)