Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct
NCT ID: NCT05008588
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2022-05-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Conditioned medium combined with Umbilical cord mesenchymal stem cells treatment
Intranasal of 3 cc of conditioned medium each, for 3 days in a row and Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
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
Umbilical cord mesenchymal stem cells treatment
Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
Umbilical Cord Mesenchymal Stem Cells
Intra-parenchymal transplantation of 20x10\^6 UC-MSCs
Standard treatment (control)
Neurologic and Neutrophic Drugs
Neurologic and Neutrophic Drugs
Such as clopidogrel, piracetam, citicoline
Interventions
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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
Neurologic and Neutrophic Drugs
Such as clopidogrel, piracetam, citicoline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
60 Years
ALL
No
Sponsors
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PT. Prodia Stem Cell Indonesia
INDUSTRY
Responsible Party
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Principal Investigators
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Rima Haifa
Role: PRINCIPAL_INVESTIGATOR
Prodia StemCell Indonesia
Locations
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Gatot Soebroto Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
PT Prodia StemCell Indonesia
Jakarta, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT/STROKE/PSI/2021
Identifier Type: -
Identifier Source: org_study_id
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