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

NCT05232903 | Unknown Phase 1 DMC

• 1 other identifier: SICH-SVF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Spontaneous Intracerebral Hemorrhage

Keywords

Spontaneous intracerebral hemorrhage; Stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events

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

  1 year

Secondary Outcomes (3)

• The changes in stroke-related neurologic deficit

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

• The changes in patients' language function

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

• The changes in patients' sensorimotor function

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

Study Arms (3)

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

EXPERIMENTAL

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.

Biological: SVF therapy group

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

EXPERIMENTAL

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.

Biological: SVF therapy group

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

EXPERIMENTAL

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.

Biological: SVF therapy group

Interventions

SVF therapy group BIOLOGICAL

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

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)

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• \) 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Central Study Contacts

Yong Cao, M.D.

CONTACT

861067096510; caoyong@bjtth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 10, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CN (1)