A clinical trial to evaluate the efficacy and safety of NOVOCART® Inject plus in the treatment of cartilage defects of the knee.

Phase 1

• Conditions: Repair of cartilage defects of the knee (medial or lateral femoral condyle or tibial plateau, trochlea or patella) caused by traumatic events or osteochondritis dissecans (defect size is = 4 and = 12cm²).; MedDRA version: 20.0Level: LLTClassification code 10007702Term: Cartilage biopsySystem Organ Class: 100000004848; MedDRA version: 20.0Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10064112Term: Cartilage graftSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2016-002817-22-LT
• Lead Sponsor: TETEC Tissue Engineering Technologies - AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Pre-operative inclusion criteria:
At visit 1 patients must meet the following inclusion criteria for enrollment; all criteria must be answered with yes” before the patient is scheduled for tissue harvest:
1.Patient is = 18 and = 65 years old at screening. Pediatric patients (14 to 17 years) with closed epiphysis may be included in selected countries. Closure of the distal femoral epiphysis of the target knee needs to be confirmed by MRI or x-ray.
2.Patients with focal articular cartilage defect(s) of the femoral condyle (medial or lateral), the trochlea, the patella or the tibial plateau (medial or lateral) of the knee.
3.Patient has one or two defects in the target knee with a defect-grade of III or IV according to the International Cartilage Repair Society (ICRS) classification or grade III or IV ICRS classification of osteochondritis dissecans lesions (ICRS-OCD).
4.If the patient has only one grade III or IV defect, the size of the defect is = 4 and = 12 cm2 post debridement. If the patient has two grade III or IV cartilage defects the total defect size is = 4 and= 12 cm2 post debridement. The defects must be located on different knee joint areas and both cartilage defects are to be treated with NOVOCART® Inject plus.
5.Patient has an intact, well-contained chondral structure surrounding the defect (i.e. no diffusely thinned-out cartilage surface) and an intact articulating joint surface opposite to the defect(s) to be treated (= Grade I ICRS or ICRS-OCD classification).
6.Patient has intact menisci in the target knee; a maximum of 50% resection per meniscus is allowed. Completely healed meniscal transplants are accepted.
7.Patient has a stable knee joint or sufficiently reconstructed ligaments and no patella malalignment or a sufficiently corrected patella malalignment. Ligament repair is accepted, if performed before, during or within 6 weeks after NOVOCART® Inject plus transplantation. Correction of patella malalignment must be performed before or during NOVOCART® Inject plus transplantation.
8.Patient has free range of motion (ROM) of the affected knee joint or = 10° of active extension and flexion loss (compared to the other knee).
9.Patient has a baseline score of < 65/100 in the overall KOOS (KOOS5).
10.Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a medically accepted method of contraception until the day of NOVOCART® Inject plus transplantation.
11.Patient is willing and able to give written informed consent to participate in the study and to comply with all follow-up visits and assessments and the postoperative rehabilitation program.
Intraoperative inclusion criteria:
At visit 2, the following inclusion criteria from visit 1 need to be confirmed; all criteria must be answered with yes” before the patient is considered eligible for the study:
1.Patient is not pregnant as confirmed by urine pregnancy test before arthroscopy
2.Patients with focal articular cartilage defect(s) of the femoral condyle (medial or lateral), the trochlea, the patella or the tibial plateau (medial or lateral) of the knee.
3.Patient has one or two defects in the target knee with a defect-grade of III or IV according to the International Cartilage Repair Society (ICRS) classification or grade III or IV ICRS classification of osteochondritis dissecans lesions (ICRS-OCD).
4.If the patient has only one grade III or IV defect, the

Exclusion Criteria

Pre-operative exclusion criteria (most important listed):
At visit 1 none of the following exclusion criteria must apply to any eligible patient; all criteria must be answered with no” before the patient is scheduled for tissue harvest:
1.Patient is unable to undergo magnetic resonance imaging (MRI).
2.Patient has grade II cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
3.Patient has more than 2 grade III or IV cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
4.The cartilage defects (ICRS or ICRS-OCD grade I or III or IV) affect more than 3 out of 6 joint areas1 of the target knee.
5.Patient had a prior biologic reconstructive procedure (e.g. microfracture, mosaicplasty, chondrocyte transplantation) in the target knee at a location different from the defect location to be treated in the study. Prior biologic reconstructive procedures are accepted, if the previously treated defect is the same defect that is planned to be treated with NOVOCART® Inject plus (i.e. the prior method has failed) and these procedures were performed = 24 months prior to screening visit 1.
6.Patient had other prior surgical interventions interfering with the assessment of the NOVOCART® Inject plus treatment. Prior diagnostic arthroscopies with debridement and lavage are acceptable.
7.Patients with subchondral bone defects more than 2 mm deep (after resection of affected bone) unless adjuvant defect filling will be performed before or during NOVOCART® Inject plus transplantation.
8.Patient has degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2.
9.Patient has chronic inflammatory arthritis and/or infectious arthritis.
10.Patient has joint space narrowing > 1/3 in the target knee when compared to the other knee or < 3 mm joint space.
11.Patient has malalignment (valgus- or varus-deformity) in the target knee.
12.Patient has arthrofibrosis in the target knee.
13.Patient has diffuse chondromalacia (grade 1 ‘softening or swelling of cartilage’ according to Outerbridge allowed).
14.Patient has metabolic arthropathies (e.g. gout, pseudo-gout)
15.Patient has bilateral lower limb pain or low back pain.
16.Patient has a known systemic connective tissue disease.
17.Patient has a current uncontrolled diabetes.
18.Patient has a known history of autoimmune disease.
19.Patient has a known history of immunological suppressive disorder or is taking immunosuppressants.
20.Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to screening visit 1.
21.The patient has a history of Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS), Human T cell lymphotropic virus (HTLV), syphilis (Treponema pallidum) or active hepatitis B or C (HCV) infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
22.The patient has a history of borreliosis.
23.The patient has an active systemic or local (at the site of surgery) infection, eczematization or inflammable skin alterations.
25.Patient has a known history of osteoporosis, uncontrolled primary hyperparathyroidism or hyperthyroidism, chronic renal failure or prior pathological fractures independent of the genesis.
26.Patient has any degenerative muscular or neurological condition that would interfere with evaluation of outcome m

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified