Basal Ganglia HematomaPhase 2NCT04074408
Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration
A Phase 2 study testing stereotactic surgery and hUMSCs in people with Basal Ganglia Hematoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Basal Ganglia Hematoma
- What is being tested?
- stereotactic surgery and hUMSCs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2020to Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jianmin Zhang, Doctor, 86-13805722695, 2307010@zju.edu.cn
About this study
Official title: Intracavitary Injection of Human Umbilical Cord Mesenchymal Stem Cells in Acute Basal Ganglia Hematoma After Stereotactic Aspiration: a Randomized, Single-blind, Placebo-Controlled, Phase 2 Trial
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.
- Conditions
- Basal Ganglia Hematoma
- Being tested
- stereotactic surgery, hUMSCs, placebo
- Medical subject headings
- Basal Ganglia Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic surgeryProcedure or surgery
stereotactic aspiration surgery
hUMSCsBiological
single intracavitary infusion 1 day after stereotactic aspiration surgery
placeboBiological
single intracavitary infusion 1 day after stereotactic aspiration surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | low dose hUMSCs or high dose hUMSCs Receives: Procedure: stereotactic surgery; Biological: hUMSCs |
| Cohort 2 | Experimental | best dose of hUMSCs (from cohort 1) or placebo Receives: Procedure: stereotactic surgery; Biological: hUMSCs; Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose limiting adverse events
Measured: 3 days
Modified Rankin Scale (mRS) to measure the prognosis
The Modified Rankin Scale (mRS) measures independence rather than performance of specific tasks. Scale consists of six grades from 0 to 5; 0 denotes no symptoms and 5 indicates severe disability. For clinical purpose, mild disability range is from 0 to 2; moderate disability ranges from 3 to 4 and 5 indicates severe disability.
Measured: 3 months
National institute of Health Stroke Scale (NIHSS) to measure stroke recovery
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale used to measure stroke severity. The NIHSS includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
Measured: 3 months
Barthel Index (BI) to evaluate the self-care ability
The Barthel index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility including: help needed with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, bathing, presence of absence of fecal incontinence and urinary incontinence. Each performance item is rated on this scale with a given number of points from 0 to 10 or 0 to 15. Item scores are summed to a total score ranging from 0 to 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence. Totally dependent ranges from 0 to 20, severe dependent ranges from 21 to 60, moderate dependent ranges from 61 to 90, mild dependent ranges from 91 to 99, and 100 indicates completely independent.
Measured: 3 months
Rate of muscle strength level of the hemiplegic limb
Measured: 3 months
Secondary outcomes (4)
Mortality rate
Measured: 12 months
Change in Glasgow coma scale (GCS) score
The Glasgow coma scale (GCS) is based on a 15-point scale for estimating and categorizing the consciousness. The test measures the motor response (1 to 6), verbal response (1 to 5) and eye opening response (1 to 4). The score is determined by the sum of the score in each of the 3 categories, with a maximum score of 15 and a minimum score of 3. A lower number indicating a more severe injury and a poorer prognosis.
Measured: 1 month
Change in Glasgow outcome scale (GOS) score
The Glasgow outcome score (GOS) applies to patients with brain damage allowing the objective assessment of their recovery. This allows a prediction of the long-term course of rehabilitation to return to work and everyday life. Scale consists of five grades from 1 to 5. 1 denotes death. 2 denotes persistent vegetative state.3 denotes severe disability. 4 denotes moderate disability and 5 denotes low disability.
Measured: 12 months
MRI (T1, T2, Flair, DWI) scanning
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study startMay 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Ganglia HematomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital, University of Science and Technology of China, Zhejiang University, First Affiliated Hospital of Fujian Medical University, Jinhua Hospital, School of Medicine, Zhejiang University, Taizhou Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074408
- Sponsor's protocol ID
- SAHZJU-hUMSCs
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 26 May 2020
- Results posted
- 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 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavitary Injection of Human Umbilical Cord Mesenchymal Stem Cells in Acute Basal Ganglia Hematoma After Stereotactic Aspiration: a Randomized, Single-blind, Placebo-Controlled, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04074408
- Acronym / sponsor ID
- SAHZJU-hUMSCs
- Conditions
- Basal Ganglia Hematoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital, University of Science and Technology of China, Zhejiang University, First Affiliated Hospital of Fujian Medical University, Jinhua Hospital, School of Medicine, Zhejiang University, Taizhou Hospital
- Study start
- May 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 30 Aug 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Procedure: stereotactic surgery, Biological: hUMSCslow dose hUMSCs or high dose hUMSCs |
| Cohort 2 | Experimental | Procedure: stereotactic surgery, Biological: hUMSCs, Biological: placebobest dose of hUMSCs (from cohort 1) or placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| stereotactic surgerystereotactic aspiration surgery | Procedure or surgery | Cohort 1, Cohort 2 |
| hUMSCssingle intracavitary infusion 1 day after stereotactic aspiration surgery | Biological | Cohort 1, Cohort 2 |
| placebosingle intracavitary infusion 1 day after stereotactic aspiration surgery | Biological | Cohort 2 |
Primary outcome
Frequency of dose limiting adverse events
Time frame: 3 days
Modified Rankin Scale (mRS) to measure the prognosis
Time frame: 3 months
The Modified Rankin Scale (mRS) measures independence rather than performance of specific tasks. Scale consists of six grades from 0 to 5; 0 denotes no symptoms and 5 indicates severe disability. For clinical purpose, mild disability range is from 0 to 2; moderate disability ranges from 3 to 4 and 5 indicates severe disability.
National institute of Health Stroke Scale (NIHSS) to measure stroke recovery
Time frame: 3 months
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale used to measure stroke severity. The NIHSS includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
Barthel Index (BI) to evaluate the self-care ability
Time frame: 3 months
The Barthel index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility including: help needed with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, bathing, presence of absence of fecal incontinence and urinary incontinence. Each performance item is rated on this scale with a given number of points from 0 to 10 or 0 to 15. Item scores are summed to a total score ranging from 0 to 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence. Totally dependent ranges from 0 to 20, severe dependent ranges from 21 to 60, moderate dependent ranges from 61 to 90, mild dependent ranges from 91 to 99, and 100 indicates completely independent.
Rate of muscle strength level of the hemiplegic limb
Time frame: 3 months
4 secondary outcomes
Mortality rate
Time frame: 12 months
Change in Glasgow coma scale (GCS) score
Time frame: 1 month
Change in Glasgow outcome scale (GOS) score
Time frame: 12 months
MRI (T1, T2, Flair, DWI) scanning
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic surgery and hUMSCs in people with Basal Ganglia Hematoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 May 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Zhang, Doctor (86-13805722695, 2307010@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dose limiting adverse events (time frame: 3 days). The study lists 5 primary outcomes in all. 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 26 May 2020.