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ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

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ClinicalTrials.gov Identifier: NCT02357485
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : March 27, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Plastic Surgery Education and Research Foundation
Information provided by (Responsible Party):
Peter B. Fodor MD, Fodor, Peter B, M.D.

Brief Summary:
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: ADSC Phase 1

Detailed Description:
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
Single injection of ADSC
Biological: ADSC
Single injection of ADSC




Primary Outcome Measures :
  1. Safety as Measured by Adverse Events [ Time Frame: Entire Study (1 year) ]
    Adverse Events were recorded during the entirety of the study.


Secondary Outcome Measures :
  1. Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Baseline to 1 year ]

    Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).

    WOMAC score: 0 (best) to 100 (worst)


  2. Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline to 1 year ]
    Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).

  3. Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion [ Time Frame: Baseline to 3 months ]
    Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.

  4. Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). [ Time Frame: baseline to 3 months ]
    Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • voluntarily provided written Informed Consent
  • ages 20-70
  • male or female
  • grades I-III radiologically documented OA of one or both knees
  • American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
  • knee pain graded as greater than 3 out of 10 on screening questionnaire
  • able to speak, read and understand English -

Exclusion Criteria:

  • patient parameters falling outside of the inclusion criteria
  • current oral or parenteral steroid or blood thinner use
  • hyaluronic acid-based injection to the affected knee joint within the previous six months
  • corticosteroid injection to the affected knee joint within the previous three months
  • end stage (Grade IV) OA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357485


Sponsors and Collaborators
Fodor, Peter B, M.D.
Plastic Surgery Education and Research Foundation
Investigators
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Principal Investigator: Peter B Fodor, M.D. Private Practice

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Responsible Party: Peter B. Fodor MD, Peter B. Fodor, M.D., Fodor, Peter B, M.D.
ClinicalTrials.gov Identifier: NCT02357485     History of Changes
Other Study ID Numbers: OAKnee01
First Posted: February 6, 2015    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Peter B. Fodor MD, Fodor, Peter B, M.D.:
ADSC
osteoarthritis
knee
adipose

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases