Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration

Study Purpose

A study to examine the safety and potential effectiveness of human umbilical cord mesenchymal stem cells (hUMSCs) in adults who have suffered spontaneous cerebral hemorrhage in basal ganglia. The hypothesis is that hUMSCs will be safe and can improve neurological function after intracerebral hemorrhage so that improve the prognosis of patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female participants between 30 and 75 years of age, diagnosed of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume from 10 ml to 60 ml calculated by ABC/2 formula.
  • - Within 5 days from onset to operation, and no improvement.
  • - Glasgow Coma Scale (GCS) score of 9 to 15.
  • - With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength≤grade 3.
  • - Modified Rankin scale (mRS) score≤1 in past medical history.
  • - Women of reproductive age have negative pregnancy tests.
  • - The participants or the legal guardian/representative who are suitable and willing to participate in the clinical trial and can cooperate to complete the follow-ups.

Exclusion Criteria:

  • - Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation AVM and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
  • - In the sequela stage of cerebral trauma.
  • - Hematoma involves other structures including but not limited to the thalamus and midbrain or complicated with intraventricular hemorrhage.
  • - With neurologic impairment before cerebral hemorrhage onset.
  • - Participants receiving anticoagulant or antiplatelet therapy.
  • - The disease progresses quickly.
Manifestation of cerebral herniation such as bilateral dilated pupil, disappearance of light reflex, and unstable vital signs.
  • - Active stage of infectious diseases including but not limited to HIV, hepatitis B, and C.
  • - History of poorly controlled seizures.
  • - History of severe co-morbidity (including but not limited to hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.
Coagulation dysfunction INR >1.4, PTT>37 seconds, thrombocytopenia (PLT<8×10^9/L), serum creatinine exceeded the upper limit of normal by 1.4 times, serum ALT >150U/L, and/or serum total bilirubin >1.6mg/dl.
  • - Participants with a mechanical heart valve.
Biological valves are acceptable.
  • - Participants with a risk of embolism (including but not limited to a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis).
Atrial fibrillation without mitral stenosis is acceptable.
  • - May be pregnant in the near future or already pregnant.
  • - Enrolled in this clinical trial or participating in other interventional medical research or clinical trials at the same time.
  • - Participants difficult to follow up or with poor compliance due to various reasons (including but not limited to geographical and social factors, drug or alcohol abuse).
  • - Participants or the legal guardian/representative is unable or unwilling to give the written informed consent.
  • - Vulnerable groups (including but not limited to mental retardation, abuse, inability to fully exercise informed consent).
  • - Any subject that the researchers think is not suitable for enrollment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04074408
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Basal Ganglia Hematoma
Arms & Interventions

Arms

Experimental: Cohort 1

low dose hUMSCs or high dose hUMSCs

Experimental: Cohort 2

best dose of hUMSCs (from cohort 1) or placebo

Interventions

Procedure: - stereotactic surgery

stereotactic aspiration surgery

Biological: - hUMSCs

single intracavitary infusion 1 day after stereotactic aspiration surgery

Biological: - placebo

single intracavitary infusion 1 day after stereotactic aspiration surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009

Site Contact

Jianmin Zhang, Doctor

[email protected]

86-13805722695

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