Clinical trial NCT05232903: Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).
Official title: Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spontaneous Intracerebral Hemorrhage
Keywords: Spontaneous intracerebral hemorrhage
Stromal vascular fraction
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).

Detailed description: Spontaneous intracerebral hemorrhage (SICH) is a form of brain parenchymal hemorrhage caused by various non-traumatic reasons, resulting in cerebral artery, veins or capillaries rupture. SICH is a common neurological emergency with the characteristics of rapid onset, dangerous conditions, and a high disability and fatality rate. Although the fatality rate has decreased, reflecting the progress of recent medical technologies, most patients still have persistent language or limb movement dysfunction.

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.

Eligibility criteria: Inclusion Criteria:

1. Age range: 45\~55 years old
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:

1. Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
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.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: The changes in stroke-related neurologic deficit
timeFrame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
measure: The changes in patients' language function
timeFrame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
measure: The changes in patients' sensorimotor function
timeFrame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References: