Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage (Nose2Knee)
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ClinicalTrials.gov Identifier: NCT01605201 |
Recruitment Status :
Completed
First Posted : May 24, 2012
Last Update Posted : August 27, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | May 22, 2012 | |||
First Posted Date ICMJE | May 24, 2012 | |||
Last Update Posted Date | August 27, 2018 | |||
Actual Study Start Date ICMJE | August 29, 2012 | |||
Actual Primary Completion Date | August 15, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Subjective pain relief [ Time Frame: until 24 months ] 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.
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Original Secondary Outcome Measures ICMJE |
Subjective pain relief [ Time Frame: until 24 months ] Subjective relief of pain for the patient will be assessed using the 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.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage | |||
Official Title ICMJE | Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage in the Knee After Traumatic Injury - a Phase I Clinical Trial- | |||
Brief 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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: Tissue engineered cartilage graft
Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold
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Study Arms ICMJE | Experimental: Implantation of cartilage graft
Intervention: Biological: Tissue engineered cartilage graft
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
18 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date ICMJE | August 15, 2018 | |||
Actual Primary Completion Date | August 15, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01605201 | |||
Other Study ID Numbers ICMJE | 92/11 TpP-I-2012-001 ( Other Identifier: Swissmedic ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Hospital, Basel, Switzerland | |||
Study Sponsor ICMJE | University Hospital, Basel, Switzerland | |||
Collaborators ICMJE | Deutsche Arthrose-Hilfe | |||
Investigators ICMJE |
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PRS Account | University Hospital, Basel, Switzerland | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |