Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).

Spontaneous Intracerebral Hemorrhage Clinical Trial

Official title:

Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232903
• Other study ID #: SICH-SVF
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2022
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, M.D.
• Phone: 861067096510
• Email: caoyong[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Spontaneous Intracerebral Hemorrhage

Intervention

Biological:
• SVF therapy group
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.	1 year
Secondary	The changes in stroke-related neurologic deficit	The changes in stroke-related neurologic deficit were measured by the National Institute of Health stroke scale (NIHSS), which ranges from 0 to 45. Higher scores indicate worse neurological function.	baseline, Month 1, Month 3, Month 6, Month 9, Month 12
Secondary	The changes in patients' language function	The changes in patients' language function were measured by the Western Aphasia Battery (WAB), which ranges from 0 to 100. Higher scores indicate better language function.	baseline, Month 1, Month 3, Month 6, Month 9, Month 12
Secondary	The changes in patients' sensorimotor function	The changes in patients' language function were measured by the Fugl-Meyer Assessment (FMA), which ranges from 0 to 226. Higher scores indicate better language function.	baseline, Month 1, Month 3, Month 6, Month 9, Month 12