Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

Articular Cartilage Defect Grade III or IV of the Knee Clinical Trial

Official title:

Autologous Cell Therapy Enhancement of Microfracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799876
• Other study ID #: FOG-TOH125
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2017

Study information

• Verified date: January 2019
• Source: Fondren Orthopedic Group L.L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Defect Grade III or IV of the Knee
• Cartilage Diseases

Intervention

Procedure:
• Autologous Cell

• Standard microfracture arthroscopic surgery

Locations

Country	Name	City	State
United States	Fondren Orthopedic Group, L.L.P.	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Fondren Orthopedic Group L.L.P.	InGeneron, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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