Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stroke, Ischemic
- Sponsor
- Samsung Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Categorical shift in modified Rankin scale (mRS)
- Last Updated
- 9 years ago
Overview
Brief Summary
The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.
Detailed Description
In this study, we will use autologous 'ischemic' serum that obtained at the earliest time point as possible (immediate after randomization) for the purpose of ischemic preconditioning. We have recently conducted preclinical studies on the effects of ischemic preconditioning on the MSC functions. We have evaluated the characteristics of rat MSCs after culture with fetal bovine serum (FBS) or serum obtained from rat stroke model. Compared to FBS, the use of serum obtained from rat stroke model resulted in more rapid expansion of MSCs, which reduces cell preparation time by increase in G2/M phase, decreased cell death/senescence, increased trophic factor secretion, and increased migration capacity.
Investigators
Oh Young Bang
Associate Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Men or women (women must be of non-child bearing potential), age 30-75 yrs.
- •Have a stroke that is observed within 90 days of the onset of symptoms
- •Radiologically
- •Relevant lesions within the middle cerebral artery territory (MCA) as assessed using diffusion-weighted imaging (DWI).
- •The maximum diameter of the stroke region in any dimension must be ≥15 mm.
- •Not involving more than a half of the ipsilateral periventricular zone
- •Clinically (National Institutes of Health stroke scale, NIHSS)
- •Moderate-to severe persistent neurologic deficit (NIHSS of 6-21 inclusive)
- •New onset of extremity paresis on the affected side, defined as a score of 2-4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.
- •Must be alert or drowsy but easily arousable as defined by score of 0-1 on the NIHSS Level of Consciousness question (item 1).
Exclusion Criteria
- •Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke modified Rankin score of 2 or more.
- •Have a stroke that is either
- •lacunar infarction
- •Hematologic cause of stroke
- •Recurrent or progressive stroke within 1 week at the time of screening.
- •Hematologic disorders or bone marrow suppression.
- •Have a severe medical illness
- •Severe heart failure
- •Severe febrile illness
- •Hepatic or renal dysfunction
Outcomes
Primary Outcomes
Categorical shift in modified Rankin scale (mRS)
Time Frame: 90 days after the cell treatment
Categorical shift in mRS at 90 days after the cell treatment
Secondary Outcomes
- Change of National Institutes of Health stroke scale (NIHSS)(90 days after the cell treatment)
- Early improvement of National Institutes of Health stroke scale (NIHSS)(14 days after the cell treatment)
- Dichotomized modified Rankin scale (mRS)(90 days after the cell treatment)
- Change of modified Rankin scale (mRS)(90 days after the cell treatment)
- Dichotomized modified Barthel index (mBI)(90 days after the cell treatment)
- Change of modified Barthel index (mBI)(90 days after the cell treatment)
- Change of gross motor function(90 days after the cell treatment)
- Change of Fine motor function(90 days after the cell treatment)
- Change of Mobility(90 days after the cell treatment)
- Change of mini-mental status exam (MMSE)(90 days after the cell treatment)
- Change of quality of life(90 days after the cell treatment)
- Safety outcome(During 90 days after the cell treatment)