Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

NCT01799876 | Completed

• 1 other identifier: FOG-TOH125
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Articular Cartilage Defect Grade III or IV of the Knee

Keywords

knee; cartilage; microfracture; cell therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Scores on Numerical Rating Scale

  up to 1 year

• Knee Injury and Osteoarthritis Outcomes Survey (KOOS)

  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

Study Arms (2)

Autologous Cell

EXPERIMENTAL

Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.

Procedure: Autologous Cell

Control

SHAM COMPARATOR

Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).

Procedure: Standard microfracture arthroscopic surgery

Interventions

Autologous Cell PROCEDURE

Autologous Cell

Standard microfracture arthroscopic surgery PROCEDURE

Control

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondren Orthopedic Group L.L.P.: lead
• InGeneron, Inc.: collaborator

Study Sites (1)

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Robert L Burke, MD

  Fondren Orthopedic Group L.L.P.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)