A Phase 1 interventional study of allogeneic engineered Gingival Fibroblasts (aeGF) in Osteoarthritis, Knee, sponsored by Scarcell Therapeutics S.A.S.. Recruiting at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Scarcell Therapeutics S.A.S. · Phase 1, Interventional, and Treatment
The company funding this study has developed an advanced therapy medicinal product (a cell therapy) from human donor cells which it wants to assess as a possible treatment for knee osteoarthritis (OA). Tissue from the gums of a human donor is used to make the study drug called allogeneic engineered Gingival Fibroblasts (aeGF). The purpose of this study is to evaluate the safety of a single injection of aeGF in the knee joint of participants with OA. aeGF have shown anti-inflammatory effects, pain relief and cartilage regeneration in animals and so are now being investigated as a treatment for OA in humans.
Scarcell Therapeutics SAS, has developed an advanced therapy medicinal product (a cell therapy) from human donor cells which will be assessed as a possible treatment for knee Osteoarthritis.
Tissue from the gums of a human donor is used to make the study drug called allogeneic engineered Gingival Fibroblasts (from now on aeGF). aeGF are defined as a Tissue Engineered Product (TEPs). TEPs contain cells or tissues that have been modified so that they can repair, regenerate or replace human tissue.
Preclinical studies have been completed which have shown promise in treating osteoarthritis in experimental animal models and domestic animals presenting with osteoarthritis. This study is intended to assess the safety of aeGF in humans for the first time.
In total 15 patients will be dosed with one intra-articular injection of aeGF into the knee, under ultrasound guidance .
The study duration is one year after the injection. A screening visit will take place prior to injection. Eligible participants will return for treatment with the study drug. Followed by a phone call post injection, up to a week later, to assess safety and any side effects of the injection. Hospital follow up visits will occur at 1, 3, 6, 12 and 24 months post injection.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →This is the only study on the registry with Scarcell Therapeutics S.A.S. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Evidence of OA in the medial tibiofemoral joint (MTJ) as follows:
Radiological - Kellgren-Lawrence:
Exclusion Criteria:
Grade 0, 1 or 4 on the Kellgren-Lawrence grading scale for the target knee:
A single intra-articular (IA) injection of 50 million aeGF into one osteoarthritic knee
Biological: allogeneic engineered Gingival Fibroblasts (aeGF)
single intra-articular injection of the study drug (aeGF) in the knee joint
The safety of a single IA injection of aeGF assessed by treatment-emergent adverse events (TEAEs) at 3 months
A TEAE is defined as an AE observed after starting administration of IMP. The incidence (number and percentage) of participants reporting TEAEs within 3 months after study drug administration will be tabulated. Summaries will be presented by System Organ Class (SOC) and Preferred Term (PT), and further by severity and relationship to IMP.
Time frame: At 3 months
Change in knee pain and function as assessed by KOOS questionnaire
KOOS is a self-reported patient outcome measure used to assess pain, function, quality of life, and ADL. 42 items are grouped into 5 subscales, i.e.: pain; other symptoms; function in daily living (ADL); Function in Sport and Recreation (Sport/Rec); and, knee-related quality of life. The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems.
Time frame: 1, 3, 6, 12 and 24 months assessments will be compared with baseline
Change in cartilage thickness as assessed by quantitative MRI
Cartilage change will be assessed using the semi-quantitative MRI Osteoarthritis Knee Score (MOAKS) system which is a two-digit score of area size and percentage of subregion affected by full thickness cartilage loss. MOAKS scores articular cartilage in 14 subregions across the knee in 2 dimensions: area of loss as % of subregion surface (AREA); and % of subregion that has full-thickness loss (FTL). AREA and FTL are scored as 0: None; 1: \< 10%; 2: 10-75%; 3: \>75%.
Time frame: Assessed at 12 months and compared with baseline
Change from baseline in biomarker CRP levels
Blood samples will be collected for biomarker, i.e. CRP analysis. CRP will be measured using a standard assay per local laboratory practice.
Time frame: Results at 1, 3 and 12 months will be compared with baseline
Use of rescue analgesic medication
Recording of rescue medication
Time frame: Rescue analgesic use at Day 2 and Months 1, 3, 6, 12 and 24 compared with baseline.
Change in inflammation as assessed by Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI)
Change will be assessed through a contrast enhanced MRI evaluation measuring the level of synovitis in the knee-joint. Inflammation will be measured on an 11-point synovitis score; a reduction by 2 points indicates an improvement.
Time frame: At 6 months and compared with baseline
Incidence, relatedness, severity and duration of TEAEs at 24 months
The safety of aeGF will be defined by incidence, relatedness, severity and duration of TEAEs at 24 months. The incidence (number and percentage) of participants reporting TEAEs within 24 months after study drug administration will be tabulated. Summaries will be presented by System Organ Class (SOC) and Preferred Term (PT), and further by severity and relationship to IMP.
Time frame: At 24 months
Plan to share: No
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