Recovery Following Partial Medial MeniscectomyPhase 1/2NCT00225095
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
A Phase 1/2 study testing Mesenchymal Stem Cells and Hyaluronan in people with Recovery Following Partial Medial Meniscectomy, run by Mesoblast International Sàrl at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recovery Following Partial Medial Meniscectomy
- What is being tested?
- Mesenchymal Stem Cells and Hyaluronan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2005to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Greater Chesapeake Associates
Baltimore, Maryland, 21218
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, 27704
Ortholndy
Indianapolis, Indiana, 46237
University of Southern California
Los Angeles, California, 90033
Unlimited Research
San Antonio, Texas, 78233
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960
About this study
Official title: 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
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).
Read the detailed description
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.
- Being tested
- Mesenchymal Stem Cells, Hyaluronan
- Keywords
- meniscectomy, Chondrogen, Mesenchymal Stem Cells, Osiris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsDrug
HyaluronanDrug
| Study group | Role | What they receive |
|---|---|---|
| Chondrogen - dose 1 | Active comparator | Chondrogen - 50 million cells Receives: Drug: Mesenchymal Stem Cells |
| Chondrogen - dose 2 | Active comparator | Chondrogen - 150 million cells Receives: Drug: Mesenchymal Stem Cells |
| Vehicle Control | Other | Vehicle Control Receives: Drug: Hyaluronan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meniscal Volume
Changes in meniscal volume over the course of the study as determined by MRI
Measured: 6 months
Secondary outcomes (8)
Quality of Life Questionnaire
Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).
Measured: 2 years
Visual Analog Scale (VAS)
Patient perception of pain will be documented using a single VAS pain scale.
Measured: Baseline to 2 years
Lysholm Knee Scale
Lysholm knee score will be determined according to the questionnaire
Measured: 2 years
Safety Assessment Adverse Event
Number of participants with Adverse Events.
Measured: 2 years
Safety Assessment Immunological
Number of participants with clinically significant abnormalities in immunological measures
Measured: 2 years
Safety Assessment Laboratory
Number of participants with clinically significant abnormalities in laboratory assessments
Measured: 2 years
Safety Assessment Physical Exam
Number of participants with clinically significant abnormalities in physical examinations.
Measured: 2 years
Safety Assessment Magnetic Resonance Imaging (MRI)
Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recovery Following Partial Medial MeniscectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California, Midwest Orthopedics at Rush - Chicago, IL, Unlimited Research - San Antonio, TX, Triangle Orthopaedic Associates, P.A., Orthopedic Center of Vero Beach - Vero Beach, FL, OrthoIndy, TRIA Orthopaedic Center, Greater Chesapeake Orthopaedic Associates, LLC
- Responsible party
- Sponsor
- Investigators
- Michelle Williams, Ph.D., Study director, Osiris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225095
- Sponsor's protocol ID
- Osiris 550
- Status last verified
- Dec 2021
- First submitted
- 21 Sep 2005
- Last updated
- 27 Dec 2021
- Results posted
- No
Publications
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.
PubMed 10102814Murphy 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.
PubMed 14673997Vangsness 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.
PubMed 24430407
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00225095
- Acronym / sponsor ID
- Osiris 550
- Keywords
- meniscectomy, Chondrogen, Mesenchymal Stem Cells, Osiris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mesoblast International SàrlIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern California, Midwest Orthopedics at Rush - Chicago, IL, Unlimited Research - San Antonio, TX, Triangle Orthopaedic Associates, P.A., Orthopedic Center of Vero Beach - Vero Beach, FL, OrthoIndy, TRIA Orthopaedic Center, Greater Chesapeake Orthopaedic Associates, LLC
- Study start
- Sep 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chondrogen - dose 1 | Active comparator | Drug: Mesenchymal Stem CellsChondrogen - 50 million cells |
| Chondrogen - dose 2 | Active comparator | Drug: Mesenchymal Stem CellsChondrogen - 150 million cells |
| Vehicle Control | Other | Drug: HyaluronanVehicle Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem Cells | Drug | Chondrogen - dose 1, Chondrogen - dose 2 |
| Hyaluronan | Drug | Vehicle Control |
Primary outcome
Meniscal Volume
Time frame: 6 months
Changes in meniscal volume over the course of the study as determined by MRI
8 secondary outcomes
Quality of Life Questionnaire
Time frame: 2 years
Visual Analog Scale (VAS)
Time frame: Baseline to 2 years
Lysholm Knee Scale
Time frame: 2 years
Safety Assessment Adverse Event
Time frame: 2 years
Safety Assessment Immunological
Time frame: 2 years
Safety Assessment Laboratory
Time frame: 2 years
Safety Assessment Physical Exam
Time frame: 2 years
Safety Assessment Magnetic Resonance Imaging (MRI)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Background: PubMed 10102814Pittenger 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.
- Background: PubMed 14673997Murphy 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.
- Derived from this study: PubMed 24430407Vangsness 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.
- Osiris Therapeutics, Inc. Home PageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Williams, Ph.D. study director
Osiris Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cells and Hyaluronan in people with Recovery Following Partial Medial Meniscectomy, run by Mesoblast International Sàrl at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meniscal Volume (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225095, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.