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

Primary Purpose

Ischemic Stroke

Status

Recruiting

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Conditioned Medium

Umbilical Cord Mesenchymal Stem Cells

Neurologic and Neutrophic Drugs

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, Mesenchymal Stem Cells, Conditioned Medium, Secretome

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gatot Soebroto HospitalRecruiting
PT Prodia StemCell IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment

Umbilical cord mesenchymal stem cells treatment

Standard treatment (control)

Arm Description

Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs

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

Neurologic and Neutrophic Drugs

Outcomes

Primary Outcome Measures

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

Venous blood collection

Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation

Venous blood collection

Change baseline Magnetic Resonance Imaging at 6 month after transplantation

To observe the brain development (neurogenesis)

Secondary Outcome Measures

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

modified Rankin Scale (mRS)

The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke

Full Information

NCT ID

NCT05008588

First Posted

August 1, 2021

Last Updated

September 23, 2022

Sponsor

PT. Prodia Stem Cell Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT05008588

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 30, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic stroke, Mesenchymal Stem Cells, Conditioned Medium, Secretome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment

Arm Type

Experimental

Arm Description

Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10^6 UC-MSCs

Arm Title

Umbilical cord mesenchymal stem cells treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Standard treatment (control)

Arm Type

Active Comparator

Arm Description

Neurologic and Neutrophic Drugs

Intervention Type

Biological

Intervention Name(s)

Conditioned Medium

Other Intervention Name(s)

Secretome

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Umbilical Cord Mesenchymal Stem Cells

Other Intervention Name(s)

Mesenchymal stromal cells

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Neurologic and Neutrophic Drugs

Intervention Description

Such as clopidogrel, piracetam, citicoline

Primary Outcome Measure Information:

Title

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

Description

Venous blood collection

Time Frame

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

Title

Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation

Description

Venous blood collection

Time Frame

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

Title

Change baseline Magnetic Resonance Imaging at 6 month after transplantation

Description

To observe the brain development (neurogenesis)

Time Frame

Before treatment, 6 month after transplantation

Secondary Outcome Measure Information:

Title

The National Institute of Health Stroke Scale (NIHSS) Scoring

Description

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

Time Frame

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

Title

modified Rankin Scale (mRS)

Description

The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Agus Aulia

Phone

+6281283606327

asct.prostem@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rima Haifa

Organizational Affiliation

Prodia StemCell Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gatot Soebroto Hospital

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10410

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammad Agus Aulia, dr

Phone

+6281283606327

asct.prostem@gmail.com

First Name & Middle Initial & Last Name & Degree

Muhammad Agus Aulia, dr

Facility Name

PT Prodia StemCell Indonesia

City

Jakarta

Country

Indonesia

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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