Acute Ischemic StrokePhase 1/23D MSC - QK01NCT07635758
Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke)
A Phase 1/2 study testing Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) in people with Acute Ischemic Stroke, run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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:
- Severe heart failure (NYHA Class III-IV)
- Severe febrile illness (any fever within 14 days before dosing requiring systemic anti-infective treatment)
- Primary or secondary immunodeficiency disease, or long-term or recent high-dose immunosuppressant or systemic corticosteroid therapy before screening
- Hemorrhagic disorder or bone marrow transplantation
- Any comorbidity that the investigator believes may shorten survival or limit ability to complete the study
- 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
- Uncontrolled active infection; or systemic anti-infective treatment within 7 days before dosing that the investigator assesses may shortly convert to uncontrolled active infection
- 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
- Clinically significant uncorrected electrolyte disturbances (e.g., hyperkalemia, hypernatremia) that the investigator believes may affect study assessment
- Unable to undergo head CT/MRI for any reason (e.g., cardiac pacemaker, metal implants, claustrophobia)
- History of drug abuse or alcohol abuse within the past year
- Allergy to bovine or porcine products, human serum albumin products, or known allergy to gentamicin
- Participation in another investigational drug, device study, or stem cell/immune cell therapy within 3 months before treatment
- History of blood transfusion or vaccination with attenuated/live vaccine within 3 months before screening
- 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)
- Other reasons deemed by the investigator as unsuitable for participation or inability to complete study procedures (e.g., lack of willingness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese People's Liberation Army General Hospital, First Medical Center
Beijing
Zhao Dong, 18910685535, dong_zhaozhao@126.com
About this study
Official title: 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
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).
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)
- Keywords
- Acute Ischemic Stroke，AIS, mesenchymal stem cells
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Human Placental-Derived 3D Mesenchymal Stem Cell Injection | Experimental | Not described Receives: Biological: Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) |
| Cell Culture Medium (Cell-Free) | Placebo comparator | Not described Receives: Biological: Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 90 post-treatment
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 360 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Dong, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635758
- Sponsor's protocol ID
- C2026-005
- Acronym
- 3D MSC - QK01
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07635758
- Acronym / sponsor ID
- 3D MSC - QK01 / C2026-005
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke，AIS, mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Cell Culture Medium (Cell-Free), Human Placental-Derived 3D Mesenchymal Stem Cell Injection |
Primary outcome
Proportion of Participants with Modified Rankin Scale (mRS) Score of 0-2
Time frame: Day 90 post-treatment
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
4 secondary outcomes
Proportion of Participants with mRS Score 0-2 at Day 28
Time frame: Day 28 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 180
Time frame: Day 180 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 270
Time frame: Day 270 post-treatment
Proportion of Participants with mRS Score 0-2 at Day 360
Time frame: Day 360 post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) in people with Acute Ischemic Stroke, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Dong (18910685535, dong_zhaozhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Modified Rankin Scale (mRS) Score of 0-2 (time frame: Day 90 post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.