dm+d

Unassigned

New Medicines

Novocart Inject Traumatic cartilage defects of the knee

Information

Novocart Inject
New formulation
Tetec
Tetec

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

An injectable albumin hyaluronic acid gel for autologous chondrocyte transplantation. It combines cultured chondrocytes that have been taken from the patient with an in-situ polymerizing hydrogel. It can then be injected arthroscopically.
Damage to the articular cartilage of the knee is a common orthopaedic problem which often occurs in young, active people. It can result from direct trauma, repetitive injuries, fractures, or degenerative and inflammatory conditions. People with this type of damage experience recurrent pain and swelling of the joint, locking of the knee and may be impaired in their ability to walk or participate in sports. To restore functionality of their knee, patients often opt for surgery [1].
Traumatic cartilage defects of the knee
Intraarticular

Trial or other data

Sep 21No update posted on US trial registry for PIII (NCT03319797) study [5].
May 20PIII study is no longer recruiting (NCT03319797). Collection of primary outcome data is due to complete Apr 21 [2].
May 19Retrospective RENOVO study completes [2].
Oct 17PIII study starts (NCT03319797). This is a prospective, multicentre, single-arm trial to evaluate the efficacy and safety of NOVOCART® Inject in the treatment of patients with focal cartilage defects of the knee (medial or lateral femoral condyle or tibial plateau, trochlea or patella). The study will include 100 adults between 18 and 65 years of age and pediatric patients (14 to 17 years) with closed epiphysis. Study sites include Czechia, Germany, Hungary, Lithuania and Switzerland. The trial will consist of three phases (including screening, treatment and follow-up phase) with a maximum duration of 5 years and 4 months. Treatment with NOVOCART® Inject requires 2 surgeries. During the first surgery autologous chondrocytes for transplant production will be harvested arthroscopically, then NOVOCART® Inject will be transplanted during a second surgery about 3 to 4 weeks later. In general, NOVOCART® Inject plus transplantation can be performed arthroscopically. However, depending on the defect localization, mini-arthrotomy may be indicated. All patients will be followed up for 5 years post NOVOCART® Inject transplantation with assessments at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined in the schedule of events and treatment at the end of this synopsis. NOVOCART® Inject will be applied in conjunction with a rehabilitation program according to the rehabilitation regimen defined in the clinical study protocol. The primary and secondary endpoints will be assessed after a follow-up of 24 month post NOVOCART® Inject transplantation (primary analysis). Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis). An interim analysis of efficacy and safety data will be performed when 63 patients (66% of the planned number of patients) are evaluable for the primary endpoint [2].
Dec 15Retrospective non-interventional RENOVO study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint starts. Data from 245 patients treated in Germany will be retrospectively assessed to determine safety (number of adverse drug reactions/serious adverse drug reactions) and efficacy (symptoms and functional status using IKDC 2000, International Knee Documentation Committee and KOOS, Knee injury osteoarthritis outcome score) [2].

ArtobendTraumatic cartilage defects of the knee

Information

Artobend
New molecular entity
Tetec
Tetec

Development and Regulatory status

Filing withdrawn
Filing withdrawn
None
Dec 20Filing withdrawn by company. At the time of withdrawal, the company considered that it could not yet provide additional data that the Agency required. The Agency was still evaluating the initial application and had not yet made any recommendations [7].
Apr 19TETEC is a subsidiary of B. Braun/Aesculap [3].

Category

A third-generation autologous chondrocyte implantation, a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure
Damage to the articular cartilage of the knee is a common orthopaedic problem which often occurs in young, active people. It can result from direct trauma, repetitive injuries, fractures, or degenerative and inflammatory conditions. People with this type of damage experience recurrent pain and swelling of the joint, locking of the knee and may be impaired in their ability to walk or participate in sports. To restore functionality of their knee, patients often opt for surgery [1].
Traumatic cartilage defects of the knee
Intraarticular

Further information

Yes

Trial or other data

Mar 20PIII trial (NCT01656902) completes collection of primary outcome data [6].
Dec 19Observational non-interventional NISANIK trial to evaluate the safety and efficacy of NOVOCART 3D in adult and adolescent patients (aged 14 to 50 years) with full thickness cartilage defects after the treatment with NOVOCART 3D completed earlier in Oct (AAG-O-H-1418; NCT02348697). The trial recruited 82 patients in Germany [6].
Dec 19NCT01656902 - UK sites: Royal Devon and Exeter Hospital [4]
Oct 19PIII trial (NCT01957722) is recruiting [5].
Feb 18PIII trial (NCT01656902) is no longer recruiting [2].
Dec 13PIII trial to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects starts (NCT01957722). The trial will enrol 233 adults in the US & Canada. Primary outcomes are Knee injury and Osteoarthritis Outcome Score (KOOS) - pain subdomain and function subdomain at 24 months post treatment; collection of these data is due to complete Aug 2023 [5].
Jan 13PIII trial to evaluate the safety and efficacy of NOVOCART 3D Plus in comparison with microfracture for the treatment of knee cartilage defects starts (NCT01656902). More than 6000 patients were already successfully treated with NOVOCART 3D in Europe since 2003. In order to obtain a general market authorization for NOVOCART 3D plus, this control group study is conducted, in which the superiority of the safety and effectiveness of carrier-bound Autologous Chondrocyte Transplantation with NOVOCART 3D plus compared to the standard of care microfracture surgery needs to be proven. The open-label, randomised, parallel trial is designed to recruit 261 patients in Austria, Czechia, France, Germany, Hungary, Latvia, Lithuania, Poland, Switzerland and the UK. Collection of primary outcome data (subjective IKDC score at 24 months) is due to complete May 19 [2].

Evidence based evaluations