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Completed

NCT Number: NCT01799876

Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

About this study

Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.

Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.

Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects undergoing microfracture surgery for the repair of articular cartilage
  • Osteochondral defect Grade III or IV
  • Age 18 to 68 years
  • Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
  • Written informed consent
  • Ability to speak, read and write English or Spanish

Exclusion criteria

  • Inability to speak, read and write English or Spanish
  • Evidence of malignant disorder/neoplasm in past 24 months
  • History of basal cell carcinoma
  • History of smoking and not committed to give up
  • Chronic skin conditions
  • Connective, metabolic or skin disease
  • Evidence of active infection
  • Pregnancy or lactating for female subjects
  • Diabetes Type I or II
  • Current steroid use
  • Immunosuppressive medication
  • Renal failure (creatine > 1.8 mg/dL)
  • Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
  • Inflammatory joint diseases of the knee that indicate additional, conflating therapies
  • Joint infection within the past 6 months
  • Meniscal resection of greater than 50% prior to, or at time of procedure
  • Uncorrected joint instability
  • Joint malalignment > 5 degrees

Treatment and study plan

Autologous Cell

Procedure

Standard microfracture arthroscopic surgery

Procedure

Primary outcomes

  1. Magnetic Resonance Imaging (MRI) for osteochondral defect filling

    Time frame: 12 months

    Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.

Secondary outcomes

  1. Pain Scores on Numerical Rating Scale

    Time frame: up to 1 year

  2. Knee Injury and Osteoarthritis Outcomes Survey (KOOS)

    Time frame: 12 months postop

    Survey

  3. Knee Range of Motion

    Time frame: up to 1 year

  4. Number of Patients with Adverse Events as a Measure of Safety

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Fondren Orthopedic Group L.L.P.

Other

Collaborators

  • InGeneron, Inc.

Registry information

Official study title

Autologous Cell Therapy Enhancement of Microfracture Surgery

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 27, 2013
Registry last updated
Jan 10, 2019

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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