Latest news with #KOOS
Medscape
3 days ago
- Health
- Medscape
EMA Says No to Knee Cartilage Repair Therapy Jelrix
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended refusing marketing authorization for Jelrix (autologous cartilage-derived articular chondrocytes), a product intended to repair injury-related cartilage defects in the knee. Jelrix is an advanced therapy medicinal product that uses a patient's own cartilage cells that are expanded in a lab and then implanted back into the knee to repair the defect. It was developed for patients with symptomatic cartilage defects of 2 cm² to 12 cm² whose bones have finished growing. In its decision, the EMA cited concerns about the lack of data to ensure consistent quality of the medicine through its manufacturing process and control strategy. No Verifiable Improvement The application was supported by a main study involving 100 patients with cartilage defects in the knee. The primary effectiveness measure was the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, and quality of life on a 0-100 scale, with higher scores indicating fewer symptoms. Assessments were conducted at 24 and 60 months post-treatment. Results were compared indirectly to outcomes from a separate microfracture registry rather than via a randomized control group. While patients who received Jelrix showed improvement in their KOOS scores at 24 and 60 months, the EMA noted that the study lacked a comparator group. This means the improvements could not be definitively attributed to Jelrix, as they might have resulted from the surgery and rehabilitation all participants received. Therefore, the agency concluded that the benefits of Jelrix did not outweigh its risks. The company confirmed there are no ongoing clinical trials or compassionate use/expanded access programs involving Jelrix in the EU. The applicant, Tissue Engineering Technologies AG, may request reexamination within 15 calendar days of receiving EMA's opinion. If pursued, CHMP will reassess their application based on any additional data provided.
Yahoo
27-05-2025
- General
- Yahoo
Pro-Russian Estonian politicians wanted to create their own defence structure with Russia's support
The Estonian Prosecutor General's Office has said that pro-Kremlin politicians Aivo Peterson and Dmitri Rootsi planned to create a parallel defence structure with the support of Russian military intelligence. Source: European Pravda with reference to ERR Details: State Prosecutor Triinu Olev-Aas said that Peterson and Rootsi, who are accused of treason, began creating a civil defence unit in 2022 with the support of the KOOS movement. In a crisis, this unit was to take over the functions of the armed forces. In correspondence with his associates, which the prosecution presented to the court, Peterson emphasised that the group's goal was to ensure security and perform the functions of the army in the event of a "power vacuum". The prosecution also says that Peterson and Rootsi authorised contacts with representatives of Russian military intelligence (formerly the GRU) to obtain instructions and assistance in setting up the unit. Peterson publicly claimed that the project was humanitarian in nature, but prosecutors view his actions as an attempt to form an alternative state defence structure operating under the guise of charity. "Peterson himself worked in the police for over ten years, so he knew perfectly well that defending the country is the exclusive prerogative of the state," Olev-Aas emphasised. The prosecutor is demanding that Peterson be found guilty of treason and sentenced to 17 years in prison. The prosecutor also demanded a 13-year prison sentence for Rootsi, who is accused of treason, and an 11-year prison sentence for Andrei Andronov, who is accused of non-violent acts against the Estonian Republic. Background: The judicial investigation into the case began in November 2023. It is now in its final stages, but not all of the defendants have made their closing statements. Two more hearings will take place in June. In 2023, Peterson ran for election to the Riigikogu (parliament) on a joint ticket of the United Left Party and KOOS. His election campaign was marred by a scandal related to a trip to the occupied territories of Ukraine, in particular to the cities of Mariupol and Donetsk. Support Ukrainska Pravda on Patreon!
