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Completed

NCT Number: NCT02357485

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADSC

Biological

Single injection of ADSC

Primary outcomes

  1. Safety as Measured by Adverse Events

    Time frame: Entire Study (1 year)

    Adverse Events were recorded during the entirety of the study.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fodor, Peter B, M.D.

Indiv

Collaborators

  • Plastic Surgery Education and Research Foundation

Registry information

Official study title

Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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