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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008588
• Other study ID #: CT/STROKE/PSI/2021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Muhammad Agus Aulia
• Phone: +6281283606327
• Email: asct.prostem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Biological:
• Conditioned Medium
Intranasal of 3 cc of conditioned medium each, for 3 days in a row
• Umbilical Cord Mesenchymal Stem Cells
Intra-parenchymal transplantation of 20x10^6 UC-MSCs

Procedure:
• Neurologic and Neutrophic Drugs
Such as clopidogrel, piracetam, citicoline

Locations

Country	Name	City	State
Indonesia	PT Prodia StemCell Indonesia	Jakarta
Indonesia	Gatot Soebroto Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change baseline Magnetic Resonance Imaging at 6 month after transplantation	To observe the brain development (neurogenesis)	Before treatment, 6 month after transplantation
Secondary	The National Institute of Health Stroke Scale (NIHSS) Scoring	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
Secondary	modified Rankin Scale (mRS)	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