Articular Cartilage Defects in the Knee JointPhase 3NCT01066702
Confirmatory Study of NeoCart in Knee Cartilage Repair
A Phase 3 study testing NeoCart and Microfracture in people with Articular Cartilage Defects in the Knee Joint, run by Histogenics Corporation at 31 sites in 2 countries.
Trial summary
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Articular Cartilage Defects in the Knee Joint
- What is being tested?
- NeoCart and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 31 sitesin 2 countries
- Study dates
- May 2010to Mar 2019
- Phase
- Phase 3
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- greater than 18 years old
- symptomatic articular cartilage lesion of the femur and/or trochlea
Who cannot join
- prior surgical intervention other than debridement
- arthritis
- clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States29 sites
University of New Mexico
Albuquerque, New Mexico, 87131
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
St. Lukes Medical Center
Boise, Idaho, 83702
Colorado University Boulder
Boulder, Colorado, 80304
Alpine Orthopedics & Sports Medicine
Bozeman, Montana, 59718
Rush University Medical Center
Chicago, Illinois, 60612
Ohio State University - Department of Sports Medicine
Columbus, Ohio, 43221
Steadman Hawkins Clinic - Denver
Denver, Colorado, 80111
Duke Sports Medicine
Durham, North Carolina, 27710
Shrock Clinical Research
Fort Lauderdale, Florida, 33316
OrthoIndy
Greenwood, Indiana, 46143
Grossmont Orthopedic Medical Group
La Mesa, California, 91942
The Orthopedic Specialty Hospital
Murray, Utah, 84107
Ochsner Clinic Sports Medicine
New Orleans, Louisiana, 70121
Hospital for Special Surgery
New York, New York, 10021
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
Orange, California, 92868
Jewett Orthopaedic Clinic
Orlando, Florida, 32822
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Orthopaedic Associates
Portland, Maine, 04102
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
The San Antonio Orthopaedic Group (TSAOG)
San Antonio, Texas, 78216
UCSF Mission Bay Orthopaedic Institute
San Francisco, California, 94158
Optim Healthcare
Savannah, Georgia, 31405
University of Washington
Seattle, Washington, 98195
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Southern California Orthopedic Research and Education
Van Nuys, California, 91405
Harvard Vanguard Medical Associates
West Roxbury, Massachusetts, 02467
Canada2 sites
Fowler Kennedy Sports Medicine Clinic
London, Ontario
Simon Fraser Orthopaedic Fund
New Westminster, British Columbia
About this study
Official title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
- Being tested
- NeoCart, Microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoCartBiological
implantation of an cartilagenous tissue implant derived from the patients own cells.
MicrofractureProcedure or surgery
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
| Study group | Role | What they receive |
|---|---|---|
| NeoCart | Experimental | Autologous cartilagenous tissue implant Receives: Biological: NeoCart |
| Microfracture | Active comparator | surgical intervention Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)
Measured: one year
Secondary outcomes (1)
Repair cartilage structure as measured by magnetic resonance imaging (MRI)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: company dissolution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Articular Cartilage Defects in the Knee JointStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histogenics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Belschner, Study director, Histogenics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066702
- Sponsor's protocol ID
- 8-01
- Status last verified
- Dec 2018
- First submitted
- 8 Feb 2010
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533.
PubMed 22637204Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. doi: 10.1177/0363546509333011. Epub 2009 May 15.
PubMed 19448048
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
- ClinicalTrials.gov ID
- NCT01066702
- Acronym / sponsor ID
- 8-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company dissolution
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Histogenics CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 10 Feb 2010 (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.
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeoCart | Experimental | Biological: NeoCartAutologous cartilagenous tissue implant |
| Microfracture | Active comparator | Procedure: Microfracturesurgical intervention |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- greater than 18 years old
- symptomatic articular cartilage lesion of the femur and/or trochlea
Key exclusion criteria (3 listed)
- prior surgical intervention other than debridement
- arthritis
- clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
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 |
|---|---|---|
| NeoCartimplantation of an cartilagenous tissue implant derived from the patients own cells. | Biological | NeoCart |
| Microfractureholes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed. | Procedure or surgery | Microfracture |
Primary outcome
The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)
Time frame: one year
1 secondary outcome
Repair cartilage structure as measured by magnetic resonance imaging (MRI)
Time frame: one year
Results and safety
The study was stopped early (reason given: company dissolution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 22637204Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533.
- Background: PubMed 19448048Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. doi: 10.1177/0363546509333011. Epub 2009 May 15.
- Histogenics WebSiteLink provided by the sponsor.
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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.
Andrea Belschner study director
Histogenics Corporation
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NeoCart and Microfracture in people with Articular Cartilage Defects in the Knee Joint, run by Histogenics Corporation at 31 sites in 2 countries.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: company dissolution). Results are not available in the source record.
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?
The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) (time frame: one year). 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 NCT01066702, which also lists 2 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 29 Mar 2019.