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

PT. Prodia Stem Cell Indonesia

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ischemic Stroke

Treatments: Biological: Conditioned Medium; Procedure: Neurologic and Neutrophic Drugs; Biological: Umbilical Cord Mesenchymal Stem Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT05008588

CT/STROKE/PSI/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment

Experimental group

Description:

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

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells

Biological: Conditioned Medium

Umbilical cord mesenchymal stem cells treatment

Experimental group

Description:

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

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells

Standard treatment (control)

Active Comparator group

Description:

Neurologic and Neutrophic Drugs

Treatment:

Procedure: Neurologic and Neutrophic Drugs