Articular Cartilage DamagePhase 2NCT00548119
NeoCart Phase 2 Clinical Trial
A Phase 2 study testing NeoCart and microfracture in people with Articular Cartilage Damage, run by Histogenics Corporation at 6 sites in United States.
Trial summary
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Articular Cartilage Damage
- 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
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2006to Mar 2014
- Phase
- Phase 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.
Who cannot join
- Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
TRIA Orthopedic Center
Bloomington, Minnesota
Duke Sports Medicine Center
Durham, North Carolina, 27710
Hospital for Special Surgery
New York, New York, 10021
OHSU
Portland, Oregon
UCSF
San Francisco, California, 94143
Keller Army Community Hospital
West Point, New York
About this study
Official title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.
- Conditions
- Articular Cartilage Damage
- Being tested
- NeoCart, microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoCartBiological
autologous tissue implant
microfractureProcedure or surgery
microfracture
| Study group | Role | What they receive |
|---|---|---|
| NeoCart | Experimental | Not described Receives: Biological: NeoCart |
| microfracture | Active comparator | Not described Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
Measured: One year
Secondary outcomes (1)
This study will extend the experience derived from our Phase 1 study.
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 posted23 Oct 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2009
- Study completionMar 2014
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 Cartilage DamageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histogenics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548119
- Sponsor's protocol ID
- 6-01
- Status last verified
- Mar 2014
- First submitted
- 19 Oct 2007
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson DE, Williams RJ 3rd, DeBerardino TM, Taylor DC, Ma CB, Kane MS, Crawford DC. Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Am J Sports Med. 2017 Mar;45(4):875-883. doi: 10.1177/0363546516677255. Epub 2017 Jan 9.
PubMed 28068480
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. 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
- NCT00548119
- Acronym / sponsor ID
- 6-01
- Conditions
- Articular Cartilage Damage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Histogenics CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Oct 2007 (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 objective of this study is to gather additional information regarding the performance of NeoCart to fill articular 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: NeoCart |
| microfracture | Active comparator | Procedure: microfracture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.
Key exclusion criteria (1 listed)
- Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.
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 |
|---|---|---|
| NeoCartautologous tissue implant | Biological | NeoCart |
| microfracturemicrofracture | Procedure or surgery | microfracture |
Primary outcome
The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy.
Time frame: One year
1 secondary outcome
This study will extend the experience derived from our Phase 1 study.
Time frame: One year
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 21 Apr 2014.
- Derived from this study: PubMed 28068480Anderson DE, Williams RJ 3rd, DeBerardino TM, Taylor DC, Ma CB, Kane MS, Crawford DC. Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. Am J Sports Med. 2017 Mar;45(4):875-883. doi: 10.1177/0363546516677255. Epub 2017 Jan 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NeoCart and microfracture in people with Articular Cartilage Damage, run by Histogenics Corporation at 6 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 1 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 phase mean?
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?
The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy. (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 NCT00548119, 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 21 Apr 2014.