Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke)
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese PLA General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤80 years; any gender
Body weight 45-90 kg
Diagnosed with acute ischemic stroke, with onset between 6 and 72 hours (inclusive) prior to enrollment; received thrombolysis or not planned for thrombolysis and no planned thrombectomy
NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) <2
Disqualifiers
Significant pre-stroke disability (pre-stroke modified Rankin Scale [mRS] score ≥2)；
History of intracerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after this ischemic stroke (imaging re-evaluation before planned dosing shows new bleeding within the infarct area accompanied by neurological deterioration [e.g., NIHSS total score increased ≥4 points from admission], judged by the investigator as unsuitable for clinical trial participation); or presence of cerebrovascular malformation, multiple sclerosis, severe traumatic brain injury history, encephalitis, or other conditions causing stroke-like symptoms
Uncontrolled systemic diseases, including but not limited to: hypertension (systolic BP >180 mmHg and/or diastolic BP ≥120 mmHg), diabetes (diabetic acute complications such as ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, or hypoglycemic coma within 3 months, or difficult-to-control diabetes [blood glucose >16.8 mmol/L or <2.8 mmol/L]), renal disease (eGFR <30 mL/min/1.73m²), hepatic failure (Child-Pugh Class C), severe heart failure (NYHA Class IV), severe chronic respiratory disease
History of seizure (except secondary epilepsy not currently requiring drug treatment)
Trial design
Design model
Parallel
Treatments tested in this trial
Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)
Biological/VaccineThis 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Human Placental-Derived 3D Mesenchymal Stem Cell InjectionExperimental treatment 1 intervention
Group B: Cell Culture Medium (Cell-Free)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion 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-treatmentSecondary outcomes
1
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-treatment2
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-treatment3
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
Time frame
Day 270 post-treatment4
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-treatmentOther outcomes
1
Incidence of Dose-Limiting Toxicity (DLT)
Dose-Limiting Toxicity assessed by clinical evaluation and laboratory monitoring according to predefined criteria based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLT is defined as: Grade ≥3 non-hematologic toxicity, Grade ≥4 hematologic toxicity lasting \>7 days, or any toxicity requiring dose delay \>14 days. Assessment includes: physical examination, vital signs monitoring, hematology panel, blood chemistry, and coagulation tests. % of participants with DLT events
Time frame
Throughout the dose-escalation phase (Phase I only)2
Incidence of Serious Adverse Events (SAE)
Serious Adverse Events assessed by clinical monitoring, laboratory evaluation, and radiographic imaging according to NCI-CTCAE version 5.0 and ICH E2A regulatory definitions. SAE includes: death, life-threatening event, hospitalization, disability/incapacity, congenital anomaly, or other medically important event. Assessment tools include: clinical examination, automated vital signs monitors, laboratory analyzers, and CT/MRI imaging. % of participants with SAEs
Time frame
From first dose through Day 720Sponsors and contacts
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Source ClinicalTrials.gov