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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
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

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

First Posted
December 6, 2021
Last Updated
February 12, 2022
Sponsor
Beijing Tiantan Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Email
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
Email
caoyong@bjtth.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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