Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke)

NCT07635758 | Recruiting Phase 1

• 1 other identifier: C2026-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke，AIS; mesenchymal stem cells

Outcome Measures

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

  Day 90 post-treatment

Secondary Outcomes (4)

• Proportion of Participants with mRS Score 0-2 at Day 28

  Day 28 post-treatment

• Proportion of Participants with mRS Score 0-2 at Day 180

  Day 180 post-treatment

• Proportion of Participants with mRS Score 0-2 at Day 270

  Day 270 post-treatment

• Proportion of Participants with mRS Score 0-2 at Day 360

  Day 360 post-treatment

Other Outcomes (2)

• Incidence of Dose-Limiting Toxicity (DLT)

  Throughout the dose-escalation phase (Phase I only)

• Incidence of Serious Adverse Events (SAE)

  From first dose through Day 720

Study Arms (2)

Human Placental-Derived 3D Mesenchymal Stem Cell Injection

EXPERIMENTAL

Biological: Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)

Cell Culture Medium (Cell-Free)

PLACEBO COMPARATOR

Biological: Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)

Interventions

Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) BIOLOGICAL

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.

Cell Culture Medium (Cell-Free); Human Placental-Derived 3D Mesenchymal Stem Cell Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant or legally authorized representative able to understand and provide written informed consent

You may not qualify if:

• 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)
• History of brain tumor or malignancy within the past 5 years, including concurrent second primary malignancy, except: a) radically excised non-melanoma skin cancer; b) radically treated cervical carcinoma in situ; c) radically treated papillary thyroid carcinoma; d) radically treated localized prostate cancer; e) radically treated ductal carcinoma in situ of the breast
• History of any of the following:
• Active or uncontrolled autoimmune disease (e.g., antiphospholipid antibody syndrome)
• Protein C or protein S deficiency
• Sickle cell anemia
• Deep vein thrombosis
• Pulmonary embolism
• Cerebrovascular malformation (e.g., moyamoya disease)
• Any concomitant disease or physical condition (e.g., severe arthritis, amputation, blindness, severe disability from prior stroke) that, in the investigator's judgment, would significantly interfere with accurate assessment of mRS, NIHSS, or BI scores
• Major surgery within the past 30 days (e.g., thoracotomy, cardiac surgery, abdominal surgery, intracranial surgery)
• Currently severe illness, including:

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital, First Medical Center

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhao Dong

CONTACT

18910685535; dong_zhaozhao@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)