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Can stem cells heal the brain after a stroke? new trial aims to find out

NCT ID NCT05008588

Disease control Sponsor: PT. Prodia Stem Cell Indonesia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a combination of umbilical cord stem cells (injected into the brain) and a liquid called conditioned medium (given as nose drops) in 15 people who recently had a stroke. The goal is to see if this approach is safe and can help the brain grow new cells. Researchers will measure changes in blood markers and brain scans over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
umbilical cord stem cells and conditioned medium (secretome)
What this could lead to
If it works, this could point toward a new way to help the brain repair itself after a stroke, possibly improving recovery.
What could go wrong
This is a very early, small trial (15 people) with no placebo group. The treatment involves brain injections, which carry risks like bleeding or infection. Success is far from guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

Contacts and locations

Locations

  • Gatot Soebroto Hospital

    Jakarta Pusat, DKI Jakarta, 10410, Indonesia

  • PT Prodia StemCell Indonesia

    Jakarta, Indonesia

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