Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).
NCT ID: NCT05232903
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
15 participants
INTERVENTIONAL
2022-03-01
2024-09-30
Brief Summary
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Detailed Description
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Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV)
Intravenous infusion of stromal vascular fraction (SVF) dose 0.5 x 10\^6/kg for 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation.
SVF therapy group
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV)
Intravenous infusion of stromal vascular fraction (SVF) dose 1.0 x 10\^6/kg for next 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation.
SVF therapy group
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV)
Intravenous infusion of SVF stromal vascular fraction (SVF) dose 1.5 x 10\^6/kg for final 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation.
SVF therapy group
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
Interventions
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SVF therapy group
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
Eligibility Criteria
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Inclusion Criteria
2. Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
3. Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT.
4. Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
5. Ability to provide written personal or surrogate consent.
6. Expectancy life is longer than 12 months.
7. Subject must be available for all specified assessments at the study site through the completion of the study.
8. Determining Organ function according to the following criteria:
1\) Aspartate transaminase (AST) ≤2.5×Upper limit of normal 2) Alanine transaminase (ALT) ≤2.5×Upper limit of normal 3) Total bilirubin (T-Bil) ≤1.5×Upper limit of normal 4) Serum albumin (SA) ≥3.0g/dL 5) Absolute neutrophil count（ANC）≥1.5×10\^9/L 6) Platelets (PLT) ≥150×10\^9/L 7) Hemoglobin (Hb) ≥9.0g/dL 8) Creatine kinase (CK) ≤1.5×Upper limit of normal 9) Serum amylase (AMY) and serum lipase (Lip) are within the normal range
Exclusion Criteria
2. History of epilepsy.
3. History of brain tumor.
4. History of brain trauma.
5. Pre-existing disability defined as a pre-stroke modified Rankin scale \>2.
6. Evidence of organ failure.
7. Septicemia with high fever and shock.
8. Positive for any one of hepatitis B surface antigens, e antigens, e antibodies, and core antibodies, hepatitis C virus antibodies, syphilis antibodies, or HIV antibodies positive.
9. Participation in any clinical investigation within 3 months prior to dosing.
10. Suffer from any other clinically significant medical diseases or with evidence of metal disorder.
11. The investigator or sponsor determines that participating in the trial will bring safety risks to the patients.
12. Participated in other stem cell therapy research.
13. History of drug or alcohol abuse in the past year
14. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
15. Allergic to cattle and pork products.
45 Years
55 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Dr. Yong Cao
Clinical Professor
Locations
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Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SICH-SVF
Identifier Type: -
Identifier Source: org_study_id
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