Stem cells from umbilical cords tested as new therapy for brain bleeds

NCT ID NCT06862388

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Intracerebral hemorrhage, or bleeding in the brain, often leaves people with lasting disability, and few treatments exist. Researchers are testing human umbilical cord mesenchymal stem cells, given by intravenous infusion, in adults who are in the subacute phase (3 to 10 days after bleeding). The trial first finds the highest safe dose in a small group, then compares that dose with a lower dose in a larger group. They will track serious side effects and measure changes in bleeding size, brain swelling, and neurological function over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human umbilical cord mesenchymal stem cells given by intravenous infusion
What this could lead to
If it works, this could offer a new treatment for brain bleeding that helps the brain heal and reduces disability.
What could go wrong
This is an early-stage trial with a small number of participants, so safety and benefit are still uncertain. Stem cell infusions can cause fever or allergic reactions, and serious complications like rebleeding or infection are possible.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-65 years old, gender is not limited. 2. Clinically confirmed intracerebral hemorrhage during the subacute period (3 days-10 days after onset). 3. CT confirmed as cerebral parenchymal hemorrhage, ABC/2 method to calculate the episodic hemorrhage volume of 15-30 mL (ABC/2 method hematoma volume calculation formula V (cm3) =A×B×C×1/2, A is the longest diameter of the largest level of the hematoma in the horizontal position of the CT scan (cm), B is the widest diameter of the hematoma in this plane perpendicular to the A (cm), C is the thickness of the hematoma appearing in the CT film (cm)). 4. Blood biochemical indexes meet the following conditions: 1) good coagulation function, international normalized ratio (INR) \<2; 2) alachlor aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of the normal value, and total bilirubin \<2 times the upper limit of the normal value; 3) creatinine clearance \>50 mL/min; 4) hemoglobin \>90 g/L; 5) absolute neutrophil value (ANC) ≥ 1.5×10\^9/L, absolute lymphocyte count ≥0.4×10\^9/L, platelet count ≥80×10\^9/L, and albumin \>25g/L; 6) procalcitonin (PCT) ≤2ng/mL. 5. National Institutes of Health Stroke Scale score (NIHSS) ≥5 and ≤20. 6. Pre-onset modified Ranking Scale score (mRS) ≤1. 7. Glasgow Coma Score (GCS) ≥9 points and ≥3 points on a single item. 8. Good compliance, signed informed consent by the person and/or legal guardian and able to receive follow-up visits at the specified time. Exclusion Criteria: 1. Brain midline deviation \>10 mm or brain hernia formation. 2. Patients who have undergone or intend to undergo surgical treatment to remove hematoma. 3. Secondary intracerebral hemorrhage caused by traumatic brain injury, arteriovenous malformation, intracranial aneurysm, coagulation disorders, hemorrhagic transformation after cerebral infarction, or tumors. 4. Suffering from malignant tumors, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis, etc.), hemorrhagic predisposition diseases (including all kinds of hereditary hemorrhagic disorders and acquired hemorrhagic diseases), malignant cardiac arrhythmia, cardiac insufficiency (BNP ≥1000pg/mL or left ventricular ejection fraction ≤40%), acute myocardial infarction, acute or severe infectious diseases (such as intracranial infection, severe pneumonia, sepsis, etc.) and other serious diseases that may aggravate the condition and affect the assessment of efficacy. 5. Allergy or intolerance to stem cell preparations or related medicines that need to be used in the infusion process, such as saline preparations and hormone preparations. 6. Pregnant or lactating women. 7. History of stroke disease with sequelae in the last 1 year, NIHSS score ≥ 6. 8. Subarachnoid hemorrhage, primary ventricular hemorrhage, pharmacological hemorrhagic stroke. 9. Unstable vital signs, including combined respiratory abnormalities (respiratory rate \<12 breaths/min or \>24 breaths/min, oxygen saturation ≤90%), hyperthermia (axillary temperature \>39 ℃), blood pressure ≥180/100 mmHg after antihypertensive treatment, blood glucose \>20 mmol/L. 10. Those who are participating in other clinical trials. 11. Previous history of epilepsy or current use of antiepileptic drugs. 12. Unable to accept all laboratory tests and imaging tests designed by the program due to metal implants or pacemakers in the body. 13. Inability to complete the follow-up program as required. 14. Patients or their legal guardians are unwilling to sign the written informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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Contacts and locations

Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

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