Cartilage LesionPhase 1Nose2KneeNCT01605201
Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage
A Phase 1 study testing Tissue engineered cartilage graft in people with Cartilage Lesion and Degenerative Lesion of Articular Cartilage of Knee, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Lesion, Degenerative Lesion of Articular Cartilage of Knee
- What is being tested?
- Tissue engineered cartilage graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Aug 2012to 15 Aug 2018
- Phase
- Phase 1
- 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
- Size of the defect on the femoral cartilage:one or two symptomatic lesion(s) grade III-IV from 2 cm2 to 8 cm2 at the femoral condyle and/or trochlea
- Other:
- Age: 18-55 years
- Written informed consent by the patient
Who cannot join
- Defect:
- Lesions smaller than 2cm2 or greater than 8cm2
- Total area of all lesions bigger than 8cm2
- Lesions other than on the femoral condyle and/or trochlea
- Any evidence of the following diseases in the target joint: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget disease of bone; ochronosis; acromegaly; hemochromatosis;Wilson disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
- Presence of a clinically relevant cartilage lesion on the patella (second lesion)
Show all 40Show fewer
- Patellofemoral cartilage lesion
- Presence of relevant complex knee injuries affecting bone and/or ligaments
- Osteochondritis dissecans: recent (within 1 year before baseline); depth of lesion >0.5 cm; subchondral sclerosis
- Advanced osteoarthritis (as defined by Radiographic Atlas of Osteoarthritis, grade 2-3)
- Varus or valgus malalignment exceeding 5° (kissing lesions out)
- Medical history:
- gravidity (Pregnancy)
- breast feeding
- presence of multiple severe allergies (including porcine collagen, streptomycin and penicillin)
- Osteoarthritis
- Current diagnosis of osteomyelitis
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- A blood result showing liver enzymes (serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, alkaline phosphatase) of more than 2 times the upper limit of normal or any other result that in the clinical investigator's mind is clinically important
- C-reactive protein level greater than 10 mg/L
- Uncontrolled diabetes
- Renal insufficiency
- Previous pacemaker implantation
- Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
- Mosaicplasty (osteochondral autograft transfer system)
- Microfracture performed less than 1 year before baseline
- Received hyaluronic acid intra-articular injections into the afflicted knee within the last 6 months of baseline Meniscal transplant (previous/present)
- Meniscal suture with meniscal arrows ipsilaterally (present or previous if not resorbed)
- Taking specific osteoarthritis drugs, such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin, within 2 weeks of the baseline visit
- Corticosteroid therapy by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last 2 weeks of baseline
- Chronic use of anticoagulants
- Patients with human immunodeficiency virus, hepatitis, or syphilis
- Malignancy
- Alcohol and drug (medication) abuse
- Poor general health condition as judged by investigator
- Body mass index >35 kg/m2
- Medication:chronic treatment with steroids or growth factors (immunomodulatory drugs)
- Other:
- Participation in concurrent clinical trials
- Participation in a previous clinical trial within 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage in the Knee After Traumatic Injury - a Phase I Clinical Trial-
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury.
Read the detailed description
Articular cartilage injuries are a prime target for regenerative techniques, since spontaneous healing is poor and untreated defects predispose to osteoarthritis. Common current strategies such as arthroscopic debridement, microfracture, autologous osteochondral grafting, use of allografts and autologous chondrocytes implantation (ACI) still have drawbacks such as long and complex rehabilitation times, technically challenging operation techniques, defect-size limitations, donor-site morbidity, limited graft material and high costs. Furthermore many techniques show unsatisfactory long term results due to inferior quality of repair tissue as compared to native cartilage or have yet to prove the cost versus benefit. These drawbacks could be overcome by using a tissue engineered nasal cartilage graft, thereby reducing donor site morbidity without introducing additional risk of complication or technically challenging techniques.
This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial involving 25 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts for repair of articular cartilage. The specific surgical target of the trial is the repair of one or two full-thickness cartilage defects from 2 cm2 to 8 cm2 (per lesion, not exceeding a total of 8 cm2 for all lesions) due to traumatic injury on the femoral condyle and/or trochlea of the knee.
- Being tested
- Tissue engineered cartilage graft
- Keywords
- Chondral lesions in the knee after traumatic injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue engineered cartilage graftBiological
Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold
| Study group | Role | What they receive |
|---|---|---|
| Implantation of cartilage graft | Experimental | Not described Receives: Biological: Tissue engineered cartilage graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Safety for the patient
Safety will be assessed by the incidence of adverse reactions and adverse events. Expected postoperative complications also occurring in the standard procedure are: pain, swelling and hematoma, casually post-anesthetic nausea, vomiting or fever.
Measured: until 24 months
2- Stability of the graft
It will be assessed by Magnetic Resonance Imaging (MRI) technique at 6, 12 and 24 months indicating if the graft is in place and if there are signs of complications. Parameters to be evaluated are: filling of the defect, integration of the border zone to the adjacent cartilage, intactness of the subchondral lamina, intactness of the subchondral bone, and relative signal intensities of the repair tissue compared to the adjacent native cartilage.
Measured: until 24 months
Secondary outcomes (1)
Subjective pain relief
Subjective relief of pain for the patient will be assessed using the International Cartilage Repair Society (ICRS) Cartilage Injury Evaluation Package which includes the pre- and postsurgical evaluation of general medical conditions, pain, activity level as well as functional and morphological status.
Measured: until 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study start29 Aug 2012
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
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 Cartilage LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Arthrose-Hilfe
- Responsible party
- Sponsor
- Investigators
- Marcel Jakob, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605201
- Sponsor's protocol ID
- 92/11
- Other IDs
- TpP-I-2012-001
- Acronym
- Nose2Knee
- Status last verified
- Aug 2018
- First submitted
- 22 May 2012
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mumme M, Barbero A, Miot S, Wixmerten A, Feliciano S, Wolf F, Asnaghi AM, Baumhoer D, Bieri O, Kretzschmar M, Pagenstert G, Haug M, Schaefer DJ, Martin I, Jakob M. Nasal chondrocyte-based engineered autologous cartilage tissue for repair of articular cartilage defects: an observational first-in-human trial. Lancet. 2016 Oct 22;388(10055):1985-1994. doi: 10.1016/S0140-6736(16)31658-0.
PubMed 27789021
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage in the Knee After Traumatic Injury - a Phase I Clinical Trial-
- ClinicalTrials.gov ID
- NCT01605201
- Acronym / sponsor ID
- Nose2Knee / 92/11
- Keywords
- Chondral lesions in the knee after traumatic injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Deutsche Arthrose-Hilfe
- Study start
- 29 Aug 2012 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 24 May 2012 (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 the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury.
Detailed description
Articular cartilage injuries are a prime target for regenerative techniques, since spontaneous healing is poor and untreated defects predispose to osteoarthritis. Common current strategies such as arthroscopic debridement, microfracture, autologous osteochondral grafting, use of allografts and autologous chondrocytes implantation (ACI) still have drawbacks such as long and complex rehabilitation times, technically challenging operation techniques, defect-size limitations, donor-site morbidity, limited graft material and high costs. Furthermore many techniques show unsatisfactory long term results due to inferior quality of repair tissue as compared to native cartilage or have yet to prove the cost versus benefit. These drawbacks could be overcome by using a tissue engineered nasal cartilage graft, thereby reducing donor site morbidity without introducing additional risk of complication or technically challenging techniques.
This study is a phase I, prospective, uncontrolled, investigator initiated clinical trial involving 25 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts for repair of articular cartilage. The specific surgical target of the trial is the repair of one or two full-thickness cartilage defects from 2 cm2 to 8 cm2 (per lesion, not exceeding a total of 8 cm2 for all lesions) due to traumatic injury on the femoral condyle and/or trochlea of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of cartilage graft | Experimental | Biological: Tissue engineered cartilage graft |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Size of the defect on the femoral cartilage:one or two symptomatic lesion(s) grade III-IV from 2 cm2 to 8 cm2 at the femoral condyle and/or trochlea
- Other:
- Age: 18-55 years
- Written informed consent by the patient
Key exclusion criteria (40 listed)
- Defect:
- Medical history:
- Other:
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 |
|---|---|---|
| Tissue engineered cartilage graftAutologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold | Biological | Implantation of cartilage graft |
Primary outcome
1-Safety for the patient
Time frame: until 24 months
Safety will be assessed by the incidence of adverse reactions and adverse events. Expected postoperative complications also occurring in the standard procedure are: pain, swelling and hematoma, casually post-anesthetic nausea, vomiting or fever.
2- Stability of the graft
Time frame: until 24 months
It will be assessed by Magnetic Resonance Imaging (MRI) technique at 6, 12 and 24 months indicating if the graft is in place and if there are signs of complications. Parameters to be evaluated are: filling of the defect, integration of the border zone to the adjacent cartilage, intactness of the subchondral lamina, intactness of the subchondral bone, and relative signal intensities of the repair tissue compared to the adjacent native cartilage.
1 secondary outcome
Subjective pain relief
Time frame: until 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 27 Aug 2018.
- Derived from this study: PubMed 27789021Mumme M, Barbero A, Miot S, Wixmerten A, Feliciano S, Wolf F, Asnaghi AM, Baumhoer D, Bieri O, Kretzschmar M, Pagenstert G, Haug M, Schaefer DJ, Martin I, Jakob M. Nasal chondrocyte-based engineered autologous cartilage tissue for repair of articular cartilage defects: an observational first-in-human trial. Lancet. 2016 Oct 22;388(10055):1985-1994. doi: 10.1016/S0140-6736(16)31658-0.
Related trials for Cartilage Lesion
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Active, not recruiting
Episealer® Knee System IDE Clinical Study
Degenerative Lesion of Articular Cartilage of Knee
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.
Marcel Jakob, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tissue engineered cartilage graft in people with Cartilage Lesion and Degenerative Lesion of Articular Cartilage of Knee, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 40 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 27 Aug 2018. 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 Switzerland. 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 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.
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?
1-Safety for the patient (time frame: until 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 NCT01605201, 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 27 Aug 2018.