Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

Autologous Cell Therapy Enhancement of Microfracture 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.

Study Overview

• Status: Completed
• Conditions: Articular Cartilage Defect Grade III or IV of the Knee
• Intervention / Treatment: Procedure: Autologous Cell; Procedure: Standard microfracture arthroscopic surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group, L.L.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Cell; Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.	Procedure: Autologous Cell
Sham Comparator: Control; Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).	Procedure: Standard microfracture arthroscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI) for osteochondral defect filling	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores on Numerical Rating Scale		up to 1 year
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)	Survey	12 months postop
Knee Range of Motion		up to 1 year
Number of Patients with Adverse Events as a Measure of Safety		up to 1 year

Collaborators and Investigators

• Sponsor: Fondren Orthopedic Group L.L.P.
• Collaborators: InGeneron, Inc.
• Investigators: Principal Investigator: Robert L Burke, MD, Fondren Orthopedic Group L.L.P.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: knee; cell therapy; cartilage; microfracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: FOG-TOH125