Clinical trial NCT05008588: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Mesenchymal Stem Cells
Conditioned Medium
Secretome
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Brain-Derived Neutrophic Factor at one month, 3 months and 6 months after transplantation
timeFrame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
measure: Change from baseline Vascular endothelial growth factor at one month, 3 months and 6 months after transplantation
timeFrame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
measure: Change baseline Magnetic Resonance Imaging at 6 month after transplantation
timeFrame: Before treatment, 6 month after transplantation
Secondary outcomes:
measure: The National Institute of Health Stroke Scale (NIHSS) Scoring
timeFrame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
measure: modified Rankin Scale (mRS)
timeFrame: Before treatment, one month after treatment, 3 months after treatment, and 6 month after treatment
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Gatot Soebroto Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: PT Prodia StemCell Indonesia
Study officials:
affiliation: Prodia StemCell Indonesia
name: Rima Haifa
role: PRINCIPAL_INVESTIGATOR
References: