Cartilage InjuryPhase 1/2ODPHOENIX2NCT02430558
Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft
A Phase 1/2 study testing OD-PHOENIX in people with Cartilage Injury, run by TBF Genie Tissulaire.
Trial summary
Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- OD-PHOENIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2016to 15 Jun 2021
- Phase
- Phase 1/2
- 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
- Male and female patients between the ages of 18 and 55
- osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
- Osteochondral lesion > grade II- ICRS
- One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
- Presence of disabling and clinically meaningful symptoms (subjective IKDC < 65, no improvement for 3 months)
- No significant obesity (BMI < 30)
Show all 10Show fewer
- Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
- Patient able to understand, sign and date the informed consent form
- Patient affiliated with a national health insurance system or who is the beneficiary of such as system
- Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.
Who cannot join
- - Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
- Excessive laxity or recurrent instability that could affect the score evaluation without concomitant ligamentoplasty
- Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
- Persons with cancer or a history of cancer
- Persons deprived of their freedom by a judicial or administrative decision
- Adults subject to legal protection measures or who are unable to provide their consent
About this study
Official title: Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial
Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
- Conditions
- Cartilage Injury
- Being tested
- OD-PHOENIX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OD-PHOENIXBiological
Also called Osteochondral allograft
Decellularized, freeze-dried, irradiated osteochondral allograft
| Study group | Role | What they receive |
|---|---|---|
| OD-PHOENIX | Experimental | treatment of 1 to 5 osteochondral allograft cylinders in mosaic Receives: Biological: OD-PHOENIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of IKDC score
Measured: 18 months
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 18 months
recellularization of tissue (arthroscopy and histology)
arthroscopy and histology
Measured: 18 months
integration of the tissue by imagery
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study start5 Apr 2016
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430558
- Sponsor's protocol ID
- 2015-A00002-47
- Acronym
- ODPHOENIX2
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2015
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial
- ClinicalTrials.gov ID
- NCT02430558
- Acronym / sponsor ID
- ODPHOENIX2 / 2015-A00002-47
- Conditions
- Cartilage Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 30 Apr 2015 (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.
Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OD-PHOENIX | Experimental | Biological: OD-PHOENIXtreatment of 1 to 5 osteochondral allograft cylinders in mosaic |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and female patients between the ages of 18 and 55
Key exclusion criteria (7 listed)
- - Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
- Excessive laxity or recurrent instability that could affect the score evaluation without concomitant ligamentoplasty
- Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
- Persons with cancer or a history of cancer
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 |
|---|---|---|
| OD-PHOENIXAlso: Osteochondral allograftDecellularized, freeze-dried, irradiated osteochondral allograft | Biological | OD-PHOENIX |
Primary outcome
improvement of IKDC score
Time frame: 18 months
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 18 months
recellularization of tissue (arthroscopy and histology)
Time frame: 18 months
integration of the tissue by imagery
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OD-PHOENIX in people with Cartilage Injury, run by TBF Genie Tissulaire.
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 10 inclusion and 7 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Low accrual rate). 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?
improvement of IKDC score (time frame: 18 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 27 Sep 2022.