This is a Phase I/IIa clinical trial evaluating human placental-derived 3D mesenchymal stem cell (MSC) injection in patients with acute ischemic stroke (AIS). Phase I is a single-dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Phase IIa explores preliminary efficacy. Each participant undergoes screening (up to 72 hours before treatment), a single-day treatment period, and follow-up for up to 720 days (24 months).
This study consists of two sequential phases: Phase I (Dose Escalation): A single ascending dose design to evaluate safety and tolerability of intravenous human placental-derived 3D MSC injection in AIS patients, and to establish the MTD and RP2D. Phase IIa (Expansion): A randomized, double-blind, placebo-controlled evaluation of preliminary efficacy at the RP2D. Study Duration: Screening within 72 hours of stroke onset; single-day treatment; follow-up visits through Day 720.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
This product is administered by intravenous infusion. The investigator will calculate the dosage based on the dose group assigned to each participant. Preparation: Remove the product from liquid nitrogen and immediately thaw in a 37±1°C water bath. After thawing, add 40 mL of pre-cooled (2-8°C) compound electrolyte injection to the product bag and mix well. Administration: The recommended infusion time is 30 minutes (±5 minutes) per bag.
Chinese People's Liberation Army General Hospital, First Medical Center
Beijing, China
RECRUITINGProportion of Participants with Modified Rankin Scale (mRS) Score of 0-2
Functional outcome assessed by the Modified Rankin Scale (mRS), a validated clinician-reported 7-point ordinal scale (minimum = 0, maximum = 6). Higher scores indicate worse functional outcome (0 = no symptoms, 6 = death). A score of 0-2 indicates functional independence. Assessment conducted by a trained, blinded neurologist via structured interview using the standardized mRS questionnaire. % of participants with mRS score 0-2
Time frame: Day 90 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 28
Functional outcome assessed by the Modified Rankin Scale (mRS), a validated clinician-reported 7-point ordinal scale (minimum = 0, maximum = 6). Higher scores indicate worse functional outcome (0 = no symptoms, 6 = death). A score of 0-2 indicates functional independence. Assessment conducted by a trained, blinded neurologist via structured interview using the standardized mRS questionnaire. % of participants with mRS score 0-2
Time frame: Day 28 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 180
Functional outcome assessed by the Modified Rankin Scale (mRS), a validated clinician-reported 7-point ordinal scale (minimum = 0, maximum = 6). Higher scores indicate worse functional outcome (0 = no symptoms, 6 = death). A score of 0-2 indicates functional independence. Assessment conducted by a trained, blinded neurologist via structured interview using the standardized mRS questionnaire. % of participants with mRS score 0-2
Time frame: Day 180 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 270
Functional outcome assessed by the Modified Rankin Scale (mRS), a validated clinician-reported 7-point ordinal scale (minimum = 0, maximum = 6). Higher scores indicate worse functional outcome (0 = no symptoms, 6 = death). A score of 0-2 indicates functional independence. Assessment conducted by a trained, blinded neurologist via structured interview using the standardized mRS questionnaire. % of participants with mRS score 0-2
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Time frame: Day 270 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 360
Functional outcome assessed by the Modified Rankin Scale (mRS), a validated clinician-reported 7-point ordinal scale (minimum = 0, maximum = 6). Higher scores indicate worse functional outcome (0 = no symptoms, 6 = death). A score of 0-2 indicates functional independence. Assessment conducted by a trained, blinded neurologist via structured interview using the standardized mRS questionnaire. % of participants with mRS score 0-2
Time frame: Day 360 post-treatment