aeGF intra-articular administration in patients with knee osteoarthritis

• Research type

  Research Study

• Full title

  First-in-human study to assess the safety and feasibility of intra-articular administration of allogeneic engineered gingival fibroblasts (aeGF) in patients with knee osteoarthritis

• IRAS ID

  1009739

• Contact name

  Tracey Attwood

• Contact email

  regulatory@tfscro.com

• Sponsor organisation

  Scarcell Therapeutics SAS

• Clinicaltrials.gov Identifier

  NCT06690710

• Research summary

  The purpose of the study is to evaluate safety and feasibility of one aeGF injection in the knee joint of participants with Osteoarthritis (OA). aeGF has shown anti-inflammatory effects, pain relief & cartilage regeneration in animals and so is being investigated as a treatment for OA in humans. Change in knee pain & function, rescue analgesic medication use, inflammation & cartilage, and C-reactive protein (a specific protein in the blood seen with inflammation) will be evaluated.
  Current strategies for investigational OA treatment are; Break vicious circle of inflammation; Enhance joint anabolism; Block joint catabolism ;Block neurogenic pain. However they only address one of these strategies. aeGF have shown to inhibit inflammation, improve cartilage production, stop its degradation and pain.
  Fifteen individuals ≥ 40 yrs old will participate in this study. The study ends 12 months after the knee injection. During this time one phone and six hospital visits will occur.
  Screening activities to confirm eligibility for the study include signing informed consent, review medical information and medications, physical exam, height, weight, Body Mass Index, blood pressure, heart rate and temperature, collection blood & urine samples, knee X-ray and Magnetic Resonance Imaging (MRI). If all criteria are met an intra-articular injection will be given under ultrasound guidance. The day after a telephone call takes place to enquire about side effects. The participant may be asked to come to the hospital for investigation of the knee. 1, 3, 6 & 12 months after treatment hospital visits will occur. At each visit vital signs, physical examination of the knee, safety labs and questionnaires to measure pain, symptoms and functionality of the knee will be done. Knee MRI to evaluate potential fluid accumulation and cartilage change at 6 & 12-month visit.

• REC name

  North East - York Research Ethics Committee

• REC reference

  24/NE/0220

• Date of REC Opinion

  15 May 2025

• REC opinion

  Further Information Favourable Opinion