A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).

Detailed Description
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Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year. Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.

Official Title
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A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years

Conditions
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Recovery Following Partial Medial Meniscectomy

Intervention / Treatment
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* Drug: Mesenchymal Stem Cells
* Drug: Hyaluronan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60, inclusive In need of medial meniscectomy Normal axial alignment Stable knee- previous ligament reconstruction, if stable Removal of at least 50% of the affected portion of the medial meniscus Intact articular cartilage in posterior meniscal weight-bearing zone Willingness to follow normal post-operative rehabilitation Willingness to participate in follow-up for two years from the time of meniscectomy surgery Ability to understand and willingness to sign consent form Exclusion Criteria: Pregnant or lactating ACL or other support structure damage confirmed at surgery Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area >15mm on weight-bearing aspect of femoral condyle or tibial plateau) Synvisc, steroid, or corticosteroid injections in preceding 3 months Diffuse synovitis at time of arthroscopy Inflammatory arthritis Oral steroid, methotrexate therapy Unable to follow post-operative exercise regimen or return for evaluations Active alcohol or substance abuse within 6 months of study entry Current and active tobacco product use Patient is positive for HIV Patient is positive for hepatitis (past history of Hepatitis A is allowed) Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient Indwelling pacemaker Cerebral aneurysm clips Ear, eye and penile implants with avian components Electrical indwelling device such as bone stimulator Indwelling magnets as tissue expander for future implants Known allergy to avian, bovine or porcine protein

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chondrogen - dose 1<br>Chondrogen - 50 million cells | Drug: Mesenchymal Stem Cells<br> <br> |
| Active Comparator: Chondrogen - dose 2<br>Chondrogen - 150 million cells | Drug: Mesenchymal Stem Cells<br> <br> |
| Other: Vehicle Control<br>Vehicle Control | Drug: Hyaluronan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meniscal Volume | Changes in meniscal volume over the course of the study as determined by MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire | Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score). | 2 years | 
| Visual Analog Scale (VAS) | Patient perception of pain will be documented using a single VAS pain scale. | Baseline to 2 years | 
| Lysholm Knee Scale | Lysholm knee score will be determined according to the questionnaire | 2 years | 
| Safety Assessment Adverse Event | Number of participants with Adverse Events. | 2 years | 
| Safety Assessment Immunological | Number of participants with clinically significant abnormalities in immunological measures | 2 years | 
| Safety Assessment Laboratory | Number of participants with clinically significant abnormalities in laboratory assessments | 2 years | 
| Safety Assessment Physical Exam | Number of participants with clinically significant abnormalities in physical examinations. | 2 years | 
| Safety Assessment Magnetic Resonance Imaging (MRI) | Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscectomy, Chondrogen, Mesenchymal Stem Cells, Osiris