Articular Cartilage Lesion of the KneeNCT01041885
INSTRUCT for Repair of Knee Cartilage Defects
A study testing INSTRUCT in people with Articular Cartilage Lesion of the Knee, run by CellCoTec B.V. at 6 sites in 3 countries.
Trial summary
The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Articular Cartilage Lesion of the Knee
- What is being tested?
- INSTRUCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jan 2010to Jun 2014
- Phase
- Interventional
- 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 with a symptomatic articular cartilage defect in the knee
Who cannot join
- Surgery on the study knee joint within 6 months
- Patients with significant malalignment (more than 5°)
- Patients with ligamentous instability of the knee
- Majority of the meniscus absent
- Severe osteoarthritis
- Intake of medications or treatments having an effect on bone or cartilage formation
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland4 sites
University Hospital nber 2 Dr. Jana Biziela
Bydgoszcz
NZOZ "Szpital AVIMED" sp. z o.o.
Katowice
NZOZ Endomedical
Poznan
Centrum Medycyny Sportowej (Sports Medicine Center CMS)
Warsaw
About this study
Official title: Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.
Read the detailed description
This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.
All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.
Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).
- Conditions
- Articular Cartilage Lesion of the Knee
- Being tested
- INSTRUCT
- Keywords
- knee cartilage defect repair, cartilage lesion, autologous chondrocyte, scaffold, INSTRUCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTRUCTDevice
INSTRUCT PolyActive scaffold implantation
| Study group | Role | What they receive |
|---|---|---|
| INSTRUCT | Experimental | INSTRUCT scaffold implantation Receives: Device: INSTRUCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of related adverse events
Measured: Over 24 months
Lesion filling
Measured: 3 months
Secondary outcomes (5)
Incidence of non-related adverse events
Measured: 24 months
KOOS, IKDC and pain VAS scores
Measured: At all timepoints over 24 months
Histopathology assessments
Measured: 6 or 12 months
MRI evaluation of structural repair
Measured: Discharge, 3, 6, 12 and 24 months
dGEMRIC assessment of structural repair
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionJun 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 Lesion of the KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellCoTec B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joël Guidoux, Study director, CellCoTec B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041885
- Sponsor's protocol ID
- 309-019
- Status last verified
- Feb 2015
- First submitted
- 31 Dec 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Slynarski K, de Jong WC, Snow M, Hendriks JAA, Wilson CE, Verdonk P. Single-Stage Autologous Chondrocyte-Based Treatment for the Repair of Knee Cartilage Lesions: Two-Year Follow-up of a Prospective Single-Arm Multicenter Study. Am J Sports Med. 2020 May;48(6):1327-1337. doi: 10.1177/0363546520912444. Epub 2020 Apr 8.
PubMed 32267734
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
- ClinicalTrials.gov ID
- NCT01041885
- Acronym / sponsor ID
- 309-019
- Conditions
- Articular Cartilage Lesion of the Knee
- Keywords
- knee cartilage defect repair, cartilage lesion, autologous chondrocyte, scaffold, INSTRUCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CellCoTec B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Jan 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.
The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.
Detailed description
This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.
All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.
Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INSTRUCT | Experimental | Device: INSTRUCTINSTRUCT scaffold implantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a symptomatic articular cartilage defect in the knee
Key exclusion criteria (6 listed)
- Surgery on the study knee joint within 6 months
- Patients with significant malalignment (more than 5°)
- Patients with ligamentous instability of the knee
- Majority of the meniscus absent
- Severe osteoarthritis
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 |
|---|---|---|
| INSTRUCTINSTRUCT PolyActive scaffold implantation | Device | INSTRUCT |
Primary outcome
Incidence of related adverse events
Time frame: Over 24 months
Lesion filling
Time frame: 3 months
5 secondary outcomes
Incidence of non-related adverse events
Time frame: 24 months
KOOS, IKDC and pain VAS scores
Time frame: At all timepoints over 24 months
Histopathology assessments
Time frame: 6 or 12 months
MRI evaluation of structural repair
Time frame: Discharge, 3, 6, 12 and 24 months
dGEMRIC assessment of structural repair
Time frame: 6, 12 and 24 months
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 4 Feb 2015.
- Derived from this study: PubMed 32267734Slynarski K, de Jong WC, Snow M, Hendriks JAA, Wilson CE, Verdonk P. Single-Stage Autologous Chondrocyte-Based Treatment for the Repair of Knee Cartilage Lesions: Two-Year Follow-up of a Prospective Single-Arm Multicenter Study. Am J Sports Med. 2020 May;48(6):1327-1337. doi: 10.1177/0363546520912444. Epub 2020 Apr 8.
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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.
Joël Guidoux study director
CellCoTec B.V.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTRUCT in people with Articular Cartilage Lesion of the Knee, run by CellCoTec B.V. at 6 sites in 3 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 1 inclusion and 6 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 4 Feb 2015. 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 Poland, Belgium, United Kingdom. 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.
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?
Incidence of related adverse events (time frame: Over 24 months). The study lists 2 primary outcomes in all. 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 NCT01041885, 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 4 Feb 2015.