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Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions (SVF)

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stromal vascular fraction injection in the osteoarthritic knee
Sponsored by
Dubai Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, knee chondromalacia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: knee osteoarthritis any grade knee chondromalacia grade 2 and above Exclusion Criteria: active HIV pregnant women Mental disease severe cardio vascular disease severe coagulation disorders infected tissues patients on other experimental studies within 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    knee osteoarhritis

    Arm Description

    patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis

    Outcomes

    Primary Outcome Measures

    change in pain level
    visual analog scale 0-10 ( 10 being worst)

    Secondary Outcome Measures

    percentage cartilage thickness change
    as measured by MRI

    Full Information

    First Posted
    August 2, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Dubai Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06000670
    Brief Title
    Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions
    Acronym
    SVF
    Official Title
    Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2026 (Anticipated)
    Study Completion Date
    October 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dubai Health Authority

    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
    clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and degenerative conditions of the knees
    Detailed Description
    to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee osteoarthritis, knee chondromalacia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    investigator is blinded to clinical and radiological assessments .
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    knee osteoarhritis
    Arm Type
    Experimental
    Arm Description
    patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis
    Intervention Type
    Procedure
    Intervention Name(s)
    stromal vascular fraction injection in the osteoarthritic knee
    Intervention Description
    stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.
    Primary Outcome Measure Information:
    Title
    change in pain level
    Description
    visual analog scale 0-10 ( 10 being worst)
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    percentage cartilage thickness change
    Description
    as measured by MRI
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: knee osteoarthritis any grade knee chondromalacia grade 2 and above Exclusion Criteria: active HIV pregnant women Mental disease severe cardio vascular disease severe coagulation disorders infected tissues patients on other experimental studies within 3 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amer Mansour, MD
    Phone
    +971502983375
    Email
    dramermansour@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mazen sawaf, MD
    Phone
    +971504545266
    Email
    drmax@novomed.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    DHA DHA
    Organizational Affiliation
    dubai health autority
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://stemcellrevolution.com/
    Description
    cell surgical network

    Learn more about this trial

    Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

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