Articular Cartilage DisorderPhase 3NCT01400607
Neocartilage Implant to Treat Cartilage Lesions of the Knee
A Phase 3 study testing Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) and Microfracture in people with Articular Cartilage Disorder and Degeneration; Articular Cartilage, run by ISTO Technologies, Inc. at 9 sites in United States.
Trial summary
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury
- What is being tested?
- Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) and Microfracture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2011to Sep 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Generally, the following inclusion criteria must be met, however, this is not a complete list.
- Male or Female between the ages of 18 and 60
- (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
- Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
- 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition
Who cannot join
- Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- Osteoarthritis
- Rheumatoid arthritis
- History of septic or reactive arthritis
- Gout or a history of gout or pseudo-gout in the affected knee
- Osteochondritis dissecans or osteochondral lesions of the knee with bone loss > 6mm deep
Show all 13Show fewer
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)
- Associated damage to the underlying subchondral bone requiring an osteochondral graft
- Is pregnant or breast-feeding
- Has a BMI > 35 (kg/m2)
- Has prior total meniscectomy of either knee
- Has received, within the past three months, intra-articular hyaluronic acid therapy, or steroid therapy
- Has more than two clinically relevant chondral lesion(s) on the index knee
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Sports Medicine Center
Columbus, Ohio, 43221
The Hawkins Foundation
Greenville, South Carolina, 29615
The Methodist Hospital Research Institute
Houston, Texas, 77030
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, 90045
Hospital for Special Surgery -Sports Medicine and Shoulder Service
New York, New York, 10021
Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
New York, New York, 10065
Santa Monica Orthopaedic & Sports Medicine Group
Santa Monica, California, 90404
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
Read the detailed description
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage
- Being tested
- Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft), Microfracture
- Keywords
- cartilage, knee surgery, cartilage injury, knee pain, cartilage repair, cartilage damage, cartilage lesion, cartilage defect, articular cartilage lesion, articular cartilage defect, juvenile, cells, ISTO Technologies, Neocartilage, RevaFlex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)Biological
Also called RevaFlex
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
MicrofractureOther
Also called marrow stimulation
Marrow stimulation using the microfracture technique; performed arthroscopically
| Study group | Role | What they receive |
|---|---|---|
| Neocartilage Implant | Active comparator | Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy. Receives: Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) |
| Microfracture | Other | Standard of care cartilage repair technique. Receives: Other: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
Measured: 36 months
Secondary outcomes (2)
IKDC Knee Examination
Measured: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Subject reported questionnaires
Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
Measured: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISTO Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michaela Purcell, Study director, ISTO Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400607
- Sponsor's protocol ID
- ISTO NEO-01-09-01
- Status last verified
- Sep 2016
- First submitted
- 20 Jul 2011
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
- ClinicalTrials.gov ID
- NCT01400607
- Acronym / sponsor ID
- ISTO NEO-01-09-01
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury, Defect of Articular Cartilage
- Keywords
- cartilage, knee surgery, cartilage injury, knee pain, cartilage repair, cartilage damage, cartilage lesion, cartilage defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ISTO Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 22 Jul 2011 (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.
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
Detailed description
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neocartilage Implant | Active comparator | Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy. |
| Microfracture | Other | Other: MicrofractureStandard of care cartilage repair technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally, the following inclusion criteria must be met, however, this is not a complete list.
- Male or Female between the ages of 18 and 60
- (1) or (2) articular cartilage lesions of the distal femur ranging in no more than 5 cm2 each
- Ipsilateral knee compartment has intact menisci (or meniscectomized remnant with > 5mm wide rim) and stable ligaments in the affected knee
- 3 months out from initiation of conservative non-surgical management (e.g.hyaluronic acid injection, activity modification) or previous minimal surgical intervention (e.g., arthroscopic lavage, debridement) or 12 months out from marrow stimulation for this condition
Key exclusion criteria (13 listed)
- Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
- Osteoarthritis
- Rheumatoid arthritis
- History of septic or reactive arthritis
- Gout or a history of gout or pseudo-gout in the affected knee
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 |
|---|---|---|
| Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)Also: RevaFlexThe Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells. | Biological | Neocartilage Implant |
| MicrofractureAlso: marrow stimulationMarrow stimulation using the microfracture technique; performed arthroscopically | Other | Microfracture |
Primary outcome
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
Time frame: 36 months
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
2 secondary outcomes
IKDC Knee Examination
Time frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Subject reported questionnaires
Time frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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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.
Michaela Purcell study director
ISTO Technologies, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) and Microfracture in people with Articular Cartilage Disorder and Degeneration; Articular Cartilage, run by ISTO Technologies, Inc. at 9 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 5 inclusion and 13 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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: Poor enrollment). 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?
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2017.