Cerebral Palsy (CP)Phase 1NCT07763028
Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy
A Phase 1 study testing allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) in people with Cerebral Palsy (CP), run by Gadjah Mada University at 1 site in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2024to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells in Children With Cerebral Palsy: A Pilot Study of Feasibility, Short-Term Safety, and Exploratory Outcomes
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).
Read the detailed description
Seven children aged 2-5 years with Gross Motor Function Classification System (GMFCS) levels II-V will receive a single intrathecal dose of allogeneic UCT-MSCs in addition to standard multidisciplinary care. The primary outcomes are procedural feasibility and short-term safety, including the occurrence of adverse events during the procedure, hospitalization, and throughout a 6-month follow-up period. Exploratory outcomes include changes in functional classification and spasticity. This pilot study is intended to provide preliminary safety and feasibility data to support the design of future controlled clinical trials and is not powered to evaluate treatment efficacy.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)
- Keywords
- Cerebral palsy, clinical trial, stromal cell, intrathecal, outcome, adverse event, safety
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the intrathecal administration through 6 months after intervention.
Secondary outcomes (5)
Gross Motor Function Classification System (GMFCS) Level
Gross motor function was classified using the Gross Motor Function Classification System (GMFCS), a five-level ordinal classification system ranging from Level I (least severe limitation) to Level V (most severe limitation). Changes in GMFCS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.
Measured: Baseline, Month 1, Month 3, and Month 6
Manual Ability Classification System (MACS) Level
Manual ability was classified using the Manual Ability Classification System (MACS), a five-level ordinal classification system ranging from Level I to Level V. Changes in MACS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.
Measured: Baseline, Month 1, Month 3, and Month 6
Communication Function Classification System (CFCS) Level
Communication performance was assessed using the Communication Function Classification System (CFCS), a five-level ordinal classification system describing everyday communication performance. Results were summarized descriptively and were not interpreted as evidence of treatment efficacy.
Measured: Baseline, Month 1, Month 3, and Month 6
Eating and Drinking Ability Classification System (EDACS) Level
Eating and drinking ability was classified using the Eating and Drinking Ability Classification System (EDACS), a five-level ordinal classification system. Changes in EDACS level were summarized descriptively and were not interpreted as evidence of treatment efficacy.
Measured: Baseline, Month 1, Month 3, and Month 6
Modified Ashworth Scale (MAS) Score
Spasticity was assessed using the Modified Ashworth Scale (MAS), an ordinal scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Muscle groups evaluated were assessed according to the study protocol. MAS scores were summarized descriptively because the scale is ordinal and may be influenced by positioning, participant cooperation, and assessor judgment.
Measured: Baseline, Month 1, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Siti Herini, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763028
- Sponsor's protocol ID
- KE/FK/1919/EC/2024
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells in Children With Cerebral Palsy: A Pilot Study of Feasibility, Short-Term Safety, and Exploratory Outcomes
- ClinicalTrials.gov ID
- NCT07763028
- Acronym / sponsor ID
- KE/FK/1919/EC/2024
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral palsy, clinical trial, stromal cell, intrathecal, outcome, adverse event, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Seven children aged 2-5 years with Gross Motor Function Classification System (GMFCS) levels II-V will receive a single intrathecal dose of allogeneic UCT-MSCs in addition to standard multidisciplinary care. The primary outcomes are procedural feasibility and short-term safety, including the occurrence of adverse events during the procedure, hospitalization, and throughout a 6-month follow-up period. Exploratory outcomes include changes in functional classification and spasticity. This pilot study is intended to provide preliminary safety and feasibility data to support the design of future controlled clinical trials and is not powered to evaluate treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal UCT-MSC | Experimental | Biological: allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)A single intrathecal dose of allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) at 2 × 10⁶ viable cells/kg body weight | Biological | Intrathecal UCT-MSC |
Primary outcome
Number of Participants Who Successfully Completed Intrathecal Administration of the Intended UCT-MSC Dose Without Technical Failure and Completed the 6-Month Follow-up
Time frame: From the intrathecal administration through 6 months after intervention.
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.
Number of Participants With Treatment-Emergent Adverse Events Following Intrathecal Administration of Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells
Time frame: From the intrathecal administration through 6 months after intervention.
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.
5 secondary outcomes
Gross Motor Function Classification System (GMFCS) Level
Time frame: Baseline, Month 1, Month 3, and Month 6
Manual Ability Classification System (MACS) Level
Time frame: Baseline, Month 1, Month 3, and Month 6
Communication Function Classification System (CFCS) Level
Time frame: Baseline, Month 1, Month 3, and Month 6
Eating and Drinking Ability Classification System (EDACS) Level
Time frame: Baseline, Month 1, Month 3, and Month 6
Modified Ashworth Scale (MAS) Score
Time frame: Baseline, Month 1, Month 3, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs) in people with Cerebral Palsy (CP), run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Successfully Completed Intrathecal Administration of the Intended UCT-MSC Dose Without Technical Failure and Completed the 6-Month Follow-up (time frame: From the intrathecal administration through 6 months after intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.