A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
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
1 other identifier
interventional
60
1 country
8
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2005
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 27, 2021
December 1, 2021
2.6 years
September 21, 2005
December 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Meniscal Volume
Changes in meniscal volume over the course of the study as determined by MRI
6 months
Secondary Outcomes (8)
Quality of Life Questionnaire
2 years
Visual Analog Scale (VAS)
Baseline to 2 years
Lysholm Knee Scale
2 years
Safety Assessment Adverse Event
2 years
Safety Assessment Immunological
2 years
- +3 more secondary outcomes
Study Arms (3)
Chondrogen - dose 1
ACTIVE COMPARATORChondrogen - 50 million cells
Chondrogen - dose 2
ACTIVE COMPARATORChondrogen - 150 million cells
Vehicle Control
OTHERVehicle Control
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast International Sàrllead
- University of Southern Californiacollaborator
- Midwest Orthopedics at Rush - Chicago, ILcollaborator
- Unlimited Research - San Antonio, TXcollaborator
- Triangle Orthopaedic Associates, P.A.collaborator
- Orthopedic Center of Vero Beach - Vero Beach, FLcollaborator
- OrthoIndycollaborator
- TRIA Orthopaedic Centercollaborator
- Greater Chesapeake Orthopaedic Associates, LLCcollaborator
Study Sites (8)
University of Southern California
Los Angeles, California, 90033, United States
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612, United States
Ortholndy
Indianapolis, Indiana, 46237, United States
Greater Chesapeake Associates
Baltimore, Maryland, 21218, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431, United States
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, 27704, United States
Unlimited Research
San Antonio, Texas, 78233, United States
Related Publications (3)
Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143.
PMID: 10102814BACKGROUNDMurphy JM, Fink DJ, Hunziker EB, Barry FP. Stem cell therapy in a caprine model of osteoarthritis. Arthritis Rheum. 2003 Dec;48(12):3464-74. doi: 10.1002/art.11365.
PMID: 14673997BACKGROUNDVangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.
PMID: 24430407DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Williams, Ph.D.
Osiris Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
September 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
December 27, 2021
Record last verified: 2021-12