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

NCT05008588 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CT/STROKE/PSI/2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; Mesenchymal Stem Cells; Conditioned Medium; Secretome

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  To observe the brain development (neurogenesis)

  Before treatment, 6 month after transplantation

Secondary Outcomes (2)

• The National Institute of Health Stroke Scale (NIHSS) Scoring

  Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment

• modified Rankin Scale (mRS)

  Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment

Study Arms (3)

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

Biological: Conditioned Medium; Biological: Umbilical Cord Mesenchymal Stem Cells

Umbilical cord mesenchymal stem cells treatment

EXPERIMENTAL

Intra-parenchymal transplantation of 20x10\^6 UC-MSCs

Biological: Umbilical Cord Mesenchymal Stem Cells

Standard treatment (control)

ACTIVE COMPARATOR

Neurologic and Neutrophic Drugs

Procedure: Neurologic and Neutrophic Drugs

Interventions

Conditioned Medium BIOLOGICAL

Intranasal of 3 cc of conditioned medium each, for 3 days in a row

Also known as: Secretome

Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment

Neurologic and Neutrophic Drugs PROCEDURE

Such as clopidogrel, piracetam, citicoline

Standard treatment (control)

Umbilical Cord Mesenchymal Stem Cells BIOLOGICAL

Intra-parenchymal transplantation of 20x10\^6 UC-MSCs

Also known as: Mesenchymal stromal cells

Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment; Umbilical cord mesenchymal stem cells treatment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead

Study Sites (2)

Gatot Soebroto Hospital

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

Location

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Culture Media, Conditioned; Secretome

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Culture Media; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies; Metabolome; Metabolism

Study Officials

• Rima Haifa

  Prodia StemCell Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 17, 2021
• Study Start: May 30, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

ID (2)