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Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

Safety and Efficacy of Combined Conditioned Medium With Umbilical Cord Mesenchymal Stem Cells as A Novel Strategy for Acute Stroke Infarct

NCT05008588•PT. Prodia Stem Cell Indonesia

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

25 - 60 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Gatot Soebroto Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Key Dates

Start Date

May 30, 2022

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 25, 2026

Enrollment

ESTIMATED participants

Conditions

Ischemic Stroke

Interventions

Conditioned Medium

BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cells

BIOLOGICAL

Neurologic and Neutrophic Drugs

PROCEDURE

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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