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
Qualifiers
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
Treatments tested in this trial
- Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov