Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05008588

Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gatot Soebroto Hospital, Jakarta Pusat, DKI Jakarta, Indonesia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conditioned Medium

Biological

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

Other names: Secretome

Umbilical Cord Mesenchymal Stem Cells

Biological

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

Other names: Mesenchymal stromal cells

Neurologic and Neutrophic Drugs

Procedure

Such as clopidogrel, piracetam, citicoline

Primary outcomes

  1. 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

  2. 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

  3. Change baseline Magnetic Resonance Imaging at 6 month after transplantation

    Time frame: Before treatment, 6 month after transplantation

    To observe the brain development (neurogenesis)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.