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

Primary Purpose

Spontaneous Intracerebral Hemorrhage

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SVF therapy group

About this trial

This is an interventional treatment trial for Spontaneous Intracerebral Hemorrhage focused on measuring Spontaneous intracerebral hemorrhage, Stromal vascular fraction

Eligibility Criteria

45 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age range: 45~55 years old
Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT.
Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
Ability to provide written personal or surrogate consent.
Expectancy life is longer than 12 months.
Subject must be available for all specified assessments at the study site through the completion of the study.
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:

Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
History of epilepsy.
History of brain tumor.
History of brain trauma.
Pre-existing disability defined as a pre-stroke modified Rankin scale >2.
Evidence of organ failure.
Septicemia with high fever and shock.
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.
Participation in any clinical investigation within 3 months prior to dosing.
Suffer from any other clinically significant medical diseases or with evidence of metal disorder.
The investigator or sponsor determines that participating in the trial will bring safety risks to the patients.
Participated in other stem cell therapy research.
History of drug or alcohol abuse in the past year
Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
Allergic to cattle and pork products.

Sites / Locations

Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV)

Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV)

Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Occurrence of adverse events

Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT05232903

First Posted

December 6, 2021

Last Updated

February 12, 2022

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05232903

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Anticipated)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spontaneous Intracerebral Hemorrhage

Keywords

Spontaneous intracerebral hemorrhage, Stromal vascular fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV)

Arm Type

Experimental

Arm Description

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.

Arm Title

Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV)

Arm Type

Experimental

Arm Description

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.

Arm Title

Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

SVF therapy group

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of adverse events

Description

Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The changes in stroke-related neurologic deficit

Description

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.

Time Frame

baseline, Month 1, Month 3, Month 6, Month 9, Month 12

Title

The changes in patients' language function

Description

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.

Time Frame

baseline, Month 1, Month 3, Month 6, Month 9, Month 12

Title

The changes in patients' sensorimotor function

Description

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.

Time Frame

baseline, Month 1, Month 3, Month 6, Month 9, Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age range: 45~55 years old Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive. Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT. Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset. Ability to provide written personal or surrogate consent. Expectancy life is longer than 12 months. Subject must be available for all specified assessments at the study site through the completion of the study. 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: Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc. History of epilepsy. History of brain tumor. History of brain trauma. Pre-existing disability defined as a pre-stroke modified Rankin scale >2. Evidence of organ failure. Septicemia with high fever and shock. 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. Participation in any clinical investigation within 3 months prior to dosing. Suffer from any other clinically significant medical diseases or with evidence of metal disorder. The investigator or sponsor determines that participating in the trial will bring safety risks to the patients. Participated in other stem cell therapy research. History of drug or alcohol abuse in the past year Women who are pregnant, breastfeeding, or planning to become pregnant during the trial Allergic to cattle and pork products.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Cao, M.D.

Phone

861067096510

Ext

100070

caoyong@bjtth.org

Facility Information:

Facility Name

Beijing Tiantan Hospital Affiliated to Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong Cao, M.D.

Phone

861067096510

Ext

100070

caoyong@bjtth.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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