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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00225095
Study groupRoleWhat they receive
Chondrogen - dose 1Active comparatorChondrogen - 50 million cells
Receives: Drug: Mesenchymal Stem Cells
Chondrogen - dose 2Active comparatorChondrogen - 150 million cells
Receives: Drug: Mesenchymal Stem Cells
Vehicle ControlOtherVehicle Control
Receives: Drug: Hyaluronan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Meniscal Volume

    Changes in meniscal volume over the course of the study as determined by MRI

    Measured: 6 months

Secondary outcomes (8)

  1. 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

  2. Visual Analog Scale (VAS)

    Patient perception of pain will be documented using a single VAS pain scale.

    Measured: Baseline to 2 years

  3. Lysholm Knee Scale

    Lysholm knee score will be determined according to the questionnaire

    Measured: 2 years

  4. Safety Assessment Adverse Event

    Number of participants with Adverse Events.

    Measured: 2 years

  5. Safety Assessment Immunological

    Number of participants with clinically significant abnormalities in immunological measures

    Measured: 2 years

  6. Safety Assessment Laboratory

    Number of participants with clinically significant abnormalities in laboratory assessments

    Measured: 2 years

  7. Safety Assessment Physical Exam

    Number of participants with clinically significant abnormalities in physical examinations.

    Measured: 2 years

  8. 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.

  1. First posted23 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

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)
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 10102814

  • Murphy 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 14673997

  • Vangsness 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

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.

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