Ischemic Stroke
Conditions
Keywords
Ischemic stroke, Mesenchymal Stem Cells, Conditioned Medium, Secretome
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.
Interventions
BIOLOGICALConditioned Medium
Intranasal of 3 cc of conditioned medium each, for 3 days in a row
BIOLOGICALUmbilical Cord Mesenchymal Stem Cells
Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
PROCEDURENeurologic and Neutrophic Drugs
Such as clopidogrel, piracetam, citicoline
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORRima Haifa
Prodia StemCell Indonesia
Outcome results
None listed