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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase I/IIa Clinical Trial on the Safety, Tolerability, and Preliminary Efficacy of Human Placental-Derived 3D Mesenchymal Stem Cell Injection Administered Via the Intravenous Route in Patients With Acute Ischemic Stroke (AIS): A Randomized, Double-Blind, Placebo-Controlled Study

Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke) (NCT07635758) is a Phase 1 / Phase 2 interventional studying Acute Ischemic Stroke, sponsored by Chinese PLA General Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Acute Ischemic Stroke, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years and ≤80 years; any gender 2. Body weight 45-90 kg 3. 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 4. NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) \<2 5. Participant or legally authorized representative able to understand and provide written willing to sign a consent form Who Should NOT Join This Trial: 1. Significant pre-stroke disability (pre-stroke modified Rankin Scale \[mRS\] score ≥2); 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 3. 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 4. History of seizure (except secondary epilepsy not currently requiring drug treatment) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥18 years and ≤80 years; any gender 2. Body weight 45-90 kg 3. 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 4. NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) \<2 5. Participant or legally authorized representative able to understand and provide written informed consent Exclusion Criteria: 1. Significant pre-stroke disability (pre-stroke modified Rankin Scale \[mRS\] score ≥2); 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 3. 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 4. History of seizure (except secondary epilepsy not currently requiring drug treatment) 5. 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 6. History of any of the following: 1. Active or uncontrolled autoimmune disease (e.g., antiphospholipid antibody syndrome) 2. Protein C or protein S deficiency 3. Sickle cell anemia 4. Deep vein thrombosis 5. Pulmonary embolism 6. Cerebrovascular malformation (e.g., moyamoya disease) 7. 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 8. Major surgery within the past 30 days (e.g., thoracotomy, cardiac surgery, abdominal surgery, intracranial surgery) 9. Currently severe illness, including: 1. Severe heart failure (NYHA Class III-IV) 2. Severe febrile illness (any fever within 14 days before dosing requiring systemic anti-infective treatment) 3. Primary or secondary immunodeficiency disease, or long-term or recent high-dose immunosuppressant or systemic corticosteroid therapy before screening 4. Hemorrhagic disorder or bone marrow transplantation 5. Any comorbidity that the investigator believes may shorten survival or limit ability to complete the study 6. Uncontrolled depression affecting daily life before stroke, dementia that may affect clinical assessment, or other neurological or psychiatric disorders that the investigator believes may affect study assessment 10. Uncontrolled active infection; or systemic anti-infective treatment within 7 days before dosing that the investigator assesses may shortly convert to uncontrolled active infection 11. Organ function meeting any of the following: Hematology: Absolute neutrophil count (ANC) \<1.0×10⁹/L Platelets (PLT) \<75×10⁹/L Hemoglobin (Hb) \<80 g/L Hepatic/Renal Function: Alanine aminotransferase (ALT) \>2.5×ULN Aspartate aminotransferase (AST) \>2.5×ULN Total bilirubin (TBIL) \>1.5×ULN Creatinine \>1.5×ULN Coagulation: Phase I: Not receiving anticoagulant or antithrombotic therapy: PT and APTT \>1.25×ULN, INR \>1.4; Receiving anticoagulant or antithrombotic therapy: PT and APTT \>1.5×ULN, INR \>3.0 Phase IIa: Not receiving anticoagulant therapy: APTT \>2.0×ULN or PT \>2.0×ULN; Receiving anticoagulant therapy: judged by investigator to have severe bleeding risk 12. Clinically significant uncorrected electrolyte disturbances (e.g., hyperkalemia, hypernatremia) that the investigator believes may affect study assessment 13. Unable to undergo head CT/MRI for any reason (e.g., cardiac pacemaker, metal implants, claustrophobia) 14. History of drug abuse or alcohol abuse within the past year 15. Allergy to bovine or porcine products, human serum albumin products, or known allergy to gentamicin 16. Participation in another investigational drug, device study, or stem cell/immune cell therapy within 3 months before treatment 17. History of blood transfusion or vaccination with attenuated/live vaccine within 3 months before screening 18. Pregnant or lactating women; or participants with pregnancy plans during the study period, or unwilling to use effective contraception; or females of childbearing potential with positive pregnancy test; or female participants on long-term oral contraceptives (continuous use \>30 days) 19. Other reasons deemed by the investigator as unsuitable for participation or inability to complete study procedures (e.g., lack of willingness)

Treatments Being Tested

BIOLOGICAL

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

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07635758), the sponsor (Chinese PLA General Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07635758 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07635758?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07635758?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07635758. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07635758. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.