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Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intra-articular injection of SVF plus PRP
Sponsored by
Bioheart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
  • daily pain for the previous 3 months
  • analgesics usage at least once a week
  • less than 30 minutes of morning stiffness
  • WOMAC score of ≤ 75 in the target knee
  • Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2

Exclusion Criteria:

  • evidence of secondary knee osteoarthritis
  • severe osteoarthritis (Joint space width - JSW < 2 mm)
  • prior intra articular injections within the previous one year prior to inclusion
  • patients with clinically significant systemic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SVF and PRP

    Arm Description

    Outcomes

    Primary Outcome Measures

    WOMAC (Western Ontario and McMaster Universities Arthritis Index)

    Secondary Outcome Measures

    Six minute walk distance

    Full Information

    First Posted
    March 15, 2017
    Last Updated
    March 23, 2017
    Sponsor
    Bioheart, Inc.
    Collaborators
    Anupam Hospital, RegennMed Research and Therapeutics Delhi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03089762
    Brief Title
    Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
    Official Title
    Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 12, 2012 (Actual)
    Primary Completion Date
    December 30, 2014 (Actual)
    Study Completion Date
    December 30, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bioheart, Inc.
    Collaborators
    Anupam Hospital, RegennMed Research and Therapeutics Delhi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SVF and PRP
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Intra-articular injection of SVF plus PRP
    Intervention Description
    administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
    Primary Outcome Measure Information:
    Title
    WOMAC (Western Ontario and McMaster Universities Arthritis Index)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Six minute walk distance
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients age 50 or older who present with symptomatic primary osteoarthritis of the knee daily pain for the previous 3 months analgesics usage at least once a week less than 30 minutes of morning stiffness WOMAC score of ≤ 75 in the target knee Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2 Exclusion Criteria: evidence of secondary knee osteoarthritis severe osteoarthritis (Joint space width - JSW < 2 mm) prior intra articular injections within the previous one year prior to inclusion patients with clinically significant systemic disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28629466
    Citation
    Bansal H, Comella K, Leon J, Verma P, Agrawal D, Koka P, Ichim T. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. J Transl Med. 2017 Jun 19;15(1):141. doi: 10.1186/s12967-017-1242-4.
    Results Reference
    derived

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    Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

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