Articular CartilagePhase 4NCT00158613
Study of the Treatment of Articular Repair (STAR)
A Phase 4 study testing Carticel (autologous cultured chondrocyte) implantation in people with Articular Cartilage, run by Vericel Corporation at 28 sites in 2 countries.
Trial summary
This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Articular Cartilage
- What is being tested?
- Carticel (autologous cultured chondrocyte) implantation
- How many people
- 126 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Mar 2000to Nov 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent
- Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
- Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
- Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
- patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure
Who cannot join
- see above
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
Atlanta Sports Medicine & Orthopaedic Center
Atlanta, Georgia, 30327
Beaumont Bone and Joint
Beaumont, Texas, 77707
National Naval Medical Center
Bethesda, Maryland, 20889
Children's Hospital
Boston, Massachusetts, 02115
Pro Sports Orthopedics
Brookline, Massachusetts, 02445
Physician's Clinic of Iowa
Cedar Rapids, Iowa, 52401
Midwest Orthopedics
Chicago, Illinois, 60612
Washington Orthopedic & Knee Clinic
Clinton, Maryland, 20735
University of Connecticut Health Center
Farmington, Connecticut, 06034
Brooke Army Medical Center, Fort Sam
Houston, Texas, 78234
Orthopaedics Indianapolis
Indianapolis, Indiana, 46237
Bluegrass Orthopaedics
Lexington, Kentucky, 40509
Denver/Vail Orthopedics
Lone Tree, Colorado, 80124
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, 90045
University of Minnesota
Minneapolis, Minnesota, 55454
Midwest Orthopaedic Center
Peoria, Illinois, 61602
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Advanced Orthopedic Center
Richmond, Virginia, 23294
Strong Memorial Hospital, University of Rochester
Rochester, New York, 14642
Naval Medical Center San Diego
San Diego, California, 92134
Santa Monica Orthopedic Group
Santa Monica, California, 90404
Office of Dr. Noah Weiss
Sonoma, California, 95476
Northwest Orthopedic Specialists
Spokane, Washington, 99204
Keller Army Hospital
West Point, New York, 10996
Canada3 sites
Fowler Kennedy Sports Medicine Clinic
London, Ontario, N6A 3K7
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.
This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.
- Conditions
- Articular Cartilage
- Being tested
- Carticel (autologous cultured chondrocyte) implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carticel (autologous cultured chondrocyte) implantationBiological
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the KOOS
Measured: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
Secondary outcomes (3)
Change from Baseline in the Modified Cincinnati Score
Measured: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Measured: 12mo, 24mo, 36mo, 48mo
Change from Baseline in the SF-36 Health Status Survey
Measured: 12mo, 24mo, 36mo, 48mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2000
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Articular CartilageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158613
- Sponsor's protocol ID
- CARTCEL 012-99
- Status last verified
- May 2021
- First submitted
- 8 Sep 2005
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaslav K, Cole B, Brewster R, DeBerardino T, Farr J, Fowler P, Nissen C; STAR Study Principal Investigators. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009 Jan;37(1):42-55. doi: 10.1177/0363546508322897. Epub 2008 Oct 16.
PubMed 18927254
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.
- ClinicalTrials.gov ID
- NCT00158613
- Acronym / sponsor ID
- CARTCEL 012-99
- Conditions
- Articular Cartilage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 12 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.
This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provided written informed consent
- Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
- Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
- Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
- patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure
Key exclusion criteria (1 listed)
- see above
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 |
|---|---|---|
| Carticel (autologous cultured chondrocyte) implantationEach Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap | Biological | – |
Primary outcome
Mean change from baseline in the KOOS
Time frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
3 secondary outcomes
Change from Baseline in the Modified Cincinnati Score
Time frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Time frame: 12mo, 24mo, 36mo, 48mo
Change from Baseline in the SF-36 Health Status Survey
Time frame: 12mo, 24mo, 36mo, 48mo
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 11 May 2021.
- Results publication: PubMed 18927254Zaslav K, Cole B, Brewster R, DeBerardino T, Farr J, Fowler P, Nissen C; STAR Study Principal Investigators. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009 Jan;37(1):42-55. doi: 10.1177/0363546508322897. Epub 2008 Oct 16.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carticel (autologous cultured chondrocyte) implantation in people with Articular Cartilage, run by Vericel Corporation at 28 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 5 inclusion and 1 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean change from baseline in the KOOS (time frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 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 NCT00158613, which also lists 1 linked publication.
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 11 May 2021.