Cerebral PalsyPhase 1/2NCT04314687
Stem Cell and Conditioned Medium for Cerebral Palsy
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cells, Conditioned Medium and Standard Therapy in people with Cerebral Palsy, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells, Conditioned Medium and Standard Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Oct 2021to Dec 2026
- Phase
- Phase 1/2
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as Cerebral palsy with total body involvement type
- Age between 6 month - 3 years old
- Parents requesting for cell therapy
- The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child
Who cannot join
- Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
- Have diagnosed meningitis and encephalitis
- Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
- Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
- Progressive disorder
- Regressive development disorder
- Severe anatomical abnormalities in Brain MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.
Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
- Conditions
- Cerebral Palsy
- Being tested
- Umbilical Cord Mesenchymal Stem Cells, Conditioned Medium, Standard Therapy
- Keywords
- Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem CellsBiological
Also called Allogeneic Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Conditioned MediumBiological
Also called Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium
Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product.
Standard TherapyOther
Also called Physiotheraphy
Standard therapy for cerebral palsy such as physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs + CM | Experimental | UCMSCs + CM is administered via intrathecal injection Receives: Biological: Umbilical Cord Mesenchymal Stem Cells; Biological: Conditioned Medium |
| UCMSCs | Experimental | UCMSCs is administered via intrathecal injection Receives: Biological: Umbilical Cord Mesenchymal Stem Cells |
| Standard Therapy | Active comparator | Physiotherapy Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Measured: 3 month after stem cells
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Measured: 6 month after stem cells
Gross Motor Function
Gross Motor Function Measure (GMFM)
Measured: 3 month after stem cells
Gross Motor Function
Gross Motor Function Measure (GMFM)
Measured: 6 month after stem cells
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Measured: 3 month after stem cells
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Measured: 6 month after stem cells
Secondary outcomes (2)
Chemical Marker
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Measured: 3 month after stem cells
Chemical Marker
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Measured: 6 month after stem cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start13 Oct 2021
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314687
- Sponsor's protocol ID
- CT/CP/02/2020
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
- ClinicalTrials.gov ID
- NCT04314687
- Acronym / sponsor ID
- CT/CP/02/2020
- Conditions
- Cerebral Palsy
- Keywords
- Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2020 (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.
The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.
Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UCMSCs + CM | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cells, Biological: Conditioned MediumUCMSCs + CM is administered via intrathecal injection |
| UCMSCs | Experimental | Biological: Umbilical Cord Mesenchymal Stem CellsUCMSCs is administered via intrathecal injection |
| Standard Therapy | Active comparator | Other: Standard TherapyPhysiotherapy |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed as Cerebral palsy with total body involvement type
- Age between 6 month - 3 years old
- Parents requesting for cell therapy
- The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child
Key exclusion criteria (7 listed)
- Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
- Have diagnosed meningitis and encephalitis
- Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
- Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
- Progressive disorder
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem CellsAlso: Allogeneic Mesenchymal Stem CellsThe umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product. | Biological | UCMSCs, UCMSCs + CM |
| Conditioned MediumAlso: Umbilical Cord Mesenchymal Stem Cells derived Conditioned MediumConditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product. | Biological | UCMSCs + CM |
| Standard TherapyAlso: PhysiotheraphyStandard therapy for cerebral palsy such as physiotherapy | Other | Standard Therapy |
Primary outcome
Gross Motor Function
Time frame: 3 month after stem cells
Gross Motor Function Classification System (GMFCS)
Gross Motor Function
Time frame: 6 month after stem cells
Gross Motor Function Classification System (GMFCS)
Gross Motor Function
Time frame: 3 month after stem cells
Gross Motor Function Measure (GMFM)
Gross Motor Function
Time frame: 6 month after stem cells
Gross Motor Function Measure (GMFM)
Cognitive Function
Time frame: 3 month after stem cells
Bayley Scales of Infant Development (BSID) version III
Cognitive Function
Time frame: 6 month after stem cells
Bayley Scales of Infant Development (BSID) version III
2 secondary outcomes
Chemical Marker
Time frame: 3 month after stem cells
Chemical Marker
Time frame: 6 month after stem cells
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 25 Feb 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 1/2 study testing Umbilical Cord Mesenchymal Stem Cells, Conditioned Medium and Standard Therapy in people with Cerebral Palsy, run by PT. Prodia Stem Cell Indonesia 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 4 inclusion and 7 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 25 Feb 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Gross Motor Function (time frame: 3 month after stem cells). The study lists 6 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 25 Feb 2026.