Active — Not RecruitingPhase 1/2

Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct

Indonesia15 participantsStarted 2022-05-30

Plain-language 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.

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation

Timeframe: 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

Timeframe: 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

Timeframe: Before treatment, 6 month after transplantation

Trial details

NCT IDNCT05008588

SponsorPT. Prodia Stem Cell Indonesia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Ischemic Stroke trials

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation

Timeframe: 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

Timeframe: 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

Timeframe: Before treatment, 6 month after transplantation