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

February 23, 2026 updated by: PT. Prodia Stem Cell Indonesia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • PT Prodia StemCell Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10410
        • Gatot Soebroto Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment
Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs
Biological: Conditioned Medium
Intranasal of 3 cc of conditioned medium each, for 3 days in a row
Other Names:
  • Secretome
Biological: Umbilical Cord Mesenchymal Stem Cells
Intra-parenchymal transplantation of 20x10^6 UC-MSCs
Other Names:
  • Mesenchymal stromal cells
Experimental: Umbilical cord mesenchymal stem cells treatment
Intra-parenchymal transplantation of 20x10^6 UC-MSCs
Biological: Umbilical Cord Mesenchymal Stem Cells
Intra-parenchymal transplantation of 20x10^6 UC-MSCs
Other Names:
  • Mesenchymal stromal cells
Active Comparator: Standard treatment (control)
Neurologic and Neutrophic Drugs
Procedure: Neurologic and Neutrophic Drugs
Such as clopidogrel, piracetam, citicoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Venous blood collection
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
Time Frame: Before treatment, 6 month after transplantation
To observe the brain development (neurogenesis)
Before treatment, 6 month after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke
Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Investigators

  • Principal Investigator: Rima Haifa, Prodia StemCell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/STROKE/PSI/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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