Cartilage Injuries in the Human KneeNCT00263432
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
A study testing Human allogenic chondrocytes in people with Cartilage Injuries in the Human Knee, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cartilage Injuries in the Human Knee
- What is being tested?
- Human allogenic chondrocytes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2011to 1 Jul 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Important cartilage injury in the knee
Who cannot join
- Important axis deviation
- Inflammatory joint disorder
- Severe obesity
Trial locations and contacts
1 site in 1 country.
About this study
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis
- Conditions
- Cartilage Injuries in the Human Knee
- Being tested
- Human allogenic chondrocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human allogenic chondrocytesProcedure or surgery
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Implantation of fresh human allogenic chondrocytes Receives: Procedure: Human allogenic chondrocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the cartilage injuries
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study start1 Aug 2011
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage Injuries in the Human KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Karl Fredrik Almqvist, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263432
- Sponsor's protocol ID
- 2001/245
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2005
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
- ClinicalTrials.gov ID
- NCT00263432
- Acronym / sponsor ID
- 2001/245
- Conditions
- Cartilage Injuries in the Human Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 8 Dec 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.
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Human allogenic chondrocytesImplantation of fresh human allogenic chondrocytes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Important cartilage injury in the knee
Key exclusion criteria (3 listed)
- Important axis deviation
- Inflammatory joint disorder
- Severe obesity
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 |
|---|---|---|
| Human allogenic chondrocytesImplantation of fresh human allogenic chondrocytes in human knee cartilage injuries | Procedure or surgery | 1 |
Primary outcome
Healing of the cartilage injuries
Time frame: After 2 years
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 9 Dec 2022.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Cartilage Injuries in the Human Knee
Active, not recruiting
The Hyalex First-in-Human Study
Cartilage Injury
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.
Karl Fredrik Almqvist, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human allogenic chondrocytes in people with Cartilage Injuries in the Human Knee, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Healing of the cartilage injuries (time frame: After 2 years). 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 9 Dec 2022.