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

Phase 1

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Biological: Conditioned Medium; Procedure: Neurologic and Neutrophic Drugs; Biological: Umbilical Cord Mesenchymal Stem Cells

• Registration Number: NCT05008588
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

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 Timeline

• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-17
• Study Start: 2022-05-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment	Umbilical Cord Mesenchymal Stem Cells	Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
Umbilical cord mesenchymal stem cells treatment	Umbilical Cord Mesenchymal Stem Cells	Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment	Conditioned Medium	Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
Standard treatment (control)	Neurologic and Neutrophic Drugs	Neurologic and Neutrophic Drugs

Primary Outcome Measures

Name	Time	Method
Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation	Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment	Venous blood collection
Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation	Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment	Venous blood collection
Change baseline Magnetic Resonance Imaging at 6 month after transplantation	Before treatment, 6 month after transplantation	To observe the brain development (neurogenesis)

Secondary Outcome Measures

Name	Time	Method
The National Institute of Health Stroke Scale (NIHSS) Scoring	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
modified Rankin Scale (mRS)	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

Trial Locations

Locations (2)

Gatot Soebroto Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

PT Prodia StemCell Indonesia; 🇮🇩 Jakarta, Indonesia