Ischemic StrokePhase 1/2NCT05008588
Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct
A Phase 1/2 study testing Conditioned Medium, Umbilical Cord Mesenchymal Stem Cells and Neurologic and Neutrophic Drugs in people with Ischemic Stroke, run by PT. Prodia Stem Cell Indonesia at 2 sites in Indonesia.
Trial summary
The purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Conditioned Medium, Umbilical Cord Mesenchymal Stem Cells and Neurologic and Neutrophic Drugs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesIndonesia
- Study dates
- 30 May 2022to Mar 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 25-60 years diagnosed with ischemic stroke acute phase
- The patient has had a CT scan/MRI of the brain to assess ischemic territory
- The patient must have an NIH Stroke score of 8-20
- The patient or legal assistant has obtained detailed informed consent regarding the study protocol and agreeing to participate in the study
- Patients with The Glasgow Coma Scale (GCS) score > 8
- Patients with Pt-APTT values within normal limits
Who cannot join
- Patients with recurrent stroke in the 6 months preceding the episode current stroke
- CT or MRI images show midline shift and bleeding transformation
- Participate in similar studies using CM and/or UC-MSC
- Patients who are immunocompromised and/or who are receiving therapy immunosuppressive
- Patients who cannot have a CT or MRI examination due to their condition
- Patients with impaired renal and hepatic function after the onset of ischemic stroke: Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) > 5x the upper limit of normal values and a significant increase in urea-creatinine values
- Patients with a history of malignant tumors or other severe neurologic conditions.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
PT Prodia StemCell Indonesia
Jakarta
Gatot Soebroto Hospital
Jakarta Pusat, DKI Jakarta, 10410
About this study
Official title: Safety and Efficacy of Combined Conditioned Medium With Umbilical Cord Mesenchymal Stem Cells as A Novel Strategy for Acute Stroke Infarct
The purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis.
Read the detailed description
This study has 3 arms namely CM and UC-MSCs treatment, UC-MSCs treatment only, and control. The investigator hypothesized that group of CM and UC-MSCs combination is the optimal treatment to induce neurogenesis in stroke patients.
- Conditions
- Ischemic Stroke
- Being tested
- Conditioned Medium, Umbilical Cord Mesenchymal Stem Cells, Neurologic and Neutrophic Drugs
- Keywords
- Ischemic stroke, Mesenchymal Stem Cells, Conditioned Medium, Secretome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned MediumBiological
Also called Secretome
Intranasal of 3 cc of conditioned medium each, for 3 days in a row
Umbilical Cord Mesenchymal Stem CellsBiological
Also called Mesenchymal stromal cells
Intra-parenchymal transplantation of 20x10^6 UC-MSCs
Neurologic and Neutrophic DrugsProcedure or surgery
Such as clopidogrel, piracetam, citicoline
| Study group | Role | What they receive |
|---|---|---|
| Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment | Experimental | Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs Receives: Biological: Conditioned Medium; Biological: Umbilical Cord Mesenchymal Stem Cells |
| Umbilical cord mesenchymal stem cells treatment | Experimental | Intra-parenchymal transplantation of 20x10^6 UC-MSCs Receives: Biological: Umbilical Cord Mesenchymal Stem Cells |
| Standard treatment (control) | Active comparator | Neurologic and Neutrophic Drugs Receives: Procedure: Neurologic and Neutrophic Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation
Venous blood collection
Measured: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation
Venous blood collection
Measured: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Change baseline Magnetic Resonance Imaging at 6 month after transplantation
To observe the brain development (neurogenesis)
Measured: Before treatment, 6 month after transplantation
Secondary outcomes (2)
The National Institute of Health Stroke Scale (NIHSS) Scoring
The NIH Stroke Scale (NIHSS) is a 15-item scale that is a well-validated and prognostically important measure of stroke-related neurologic deficits in research and clinical care
Measured: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
modified Rankin Scale (mRS)
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke
Measured: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 May 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rima Haifa, Principal investigator, Prodia StemCell Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008588
- Sponsor's protocol ID
- CT/STROKE/PSI/2021
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Safety and Efficacy of Combined Conditioned Medium With Umbilical Cord Mesenchymal Stem Cells as A Novel Strategy for Acute Stroke Infarct
- ClinicalTrials.gov ID
- NCT05008588
- Acronym / sponsor ID
- CT/STROKE/PSI/2021
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Mesenchymal Stem Cells, Conditioned Medium, Secretome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Aug 2021 (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 purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis.
Detailed description
This study has 3 arms namely CM and UC-MSCs treatment, UC-MSCs treatment only, and control. The investigator hypothesized that group of CM and UC-MSCs combination is the optimal treatment to induce neurogenesis in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment | Experimental | Biological: Conditioned Medium, Biological: Umbilical Cord Mesenchymal Stem CellsIntranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs |
| Umbilical cord mesenchymal stem cells treatment | Experimental | Biological: Umbilical Cord Mesenchymal Stem CellsIntra-parenchymal transplantation of 20x10^6 UC-MSCs |
| Standard treatment (control) | Active comparator | Procedure: Neurologic and Neutrophic DrugsNeurologic and Neutrophic Drugs |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female aged 25-60 years diagnosed with ischemic stroke acute phase
- The patient has had a CT scan/MRI of the brain to assess ischemic territory
- The patient must have an NIH Stroke score of 8-20
- The patient or legal assistant has obtained detailed informed consent regarding the study protocol and agreeing to participate in the study
- Patients with The Glasgow Coma Scale (GCS) score > 8
Key exclusion criteria (7 listed)
- Patients with recurrent stroke in the 6 months preceding the episode current stroke
- CT or MRI images show midline shift and bleeding transformation
- Participate in similar studies using CM and/or UC-MSC
- Patients who are immunocompromised and/or who are receiving therapy immunosuppressive
- Patients who cannot have a CT or MRI examination due to their condition
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 |
|---|---|---|
| Conditioned MediumAlso: SecretomeIntranasal of 3 cc of conditioned medium each, for 3 days in a row | Biological | Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment |
| Umbilical Cord Mesenchymal Stem CellsAlso: Mesenchymal stromal cellsIntra-parenchymal transplantation of 20x10^6 UC-MSCs | Biological | Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment, Umbilical cord mesenchymal stem cells treatment |
| Neurologic and Neutrophic DrugsSuch as clopidogrel, piracetam, citicoline | Procedure or surgery | Standard treatment (control) |
Primary outcome
Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation
Time frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Venous blood collection
Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation
Time frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Venous blood collection
Change baseline Magnetic Resonance Imaging at 6 month after transplantation
Time frame: Before treatment, 6 month after transplantation
To observe the brain development (neurogenesis)
2 secondary outcomes
The National Institute of Health Stroke Scale (NIHSS) Scoring
Time frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
modified Rankin Scale (mRS)
Time frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
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.
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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.
Rima Haifa principal investigator
Prodia StemCell Indonesia
2 sites 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 Conditioned Medium, Umbilical Cord Mesenchymal Stem Cells and Neurologic and Neutrophic Drugs in people with Ischemic Stroke, run by PT. Prodia Stem Cell Indonesia at 2 sites 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 6 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 2 sites 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?
Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation (time frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment). The study lists 3 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.