Actively Recruiting
FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis
Led by Scarcell Therapeutics S.A.S. · Updated on 2025-09-23
15
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
S
Scarcell Therapeutics S.A.S.
Lead Sponsor
T
TFS Trial Form Support
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Male or female participants aged 60 years or older
- Clinical evidence of knee pain from osteoarthritis in the medial tibiofemoral joint
- Radiological evidence of OA grade 2 or 3 on the Kellgren-Lawrence scale
- Minimal joint space width of 2.5 mm on knee x-ray
- Pain score of 3 or higher on a 0-10 visual analogue scale at screening
You will not qualify if you...
- Kellgren-Lawrence grade 0, 1, or 4 in the target knee
- Severe knee misalignment greater than 10 degrees varus or valgus
- Osteoarthritis caused by other conditions such as joint dysplasia, osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition, neuropathic arthropathy, trauma, rheumatoid arthritis, gout, psoriatic arthritis, autoimmune arthritis, or spondylitis
- Use of any investigational drug or experimental therapy within 3 months before screening
- Use of corticosteroids or immunosuppressants before screening
- Intra-articular steroid or hyaluronic acid treatments within 3 months before day 1
- Planned major surgery such as joint replacement within 2 months after injection
- Previous surgery on the target knee including diagnostic arthroscopy
- Skin lesions or infections at the injection site
- Any known active infection
- Abnormal blood or coagulation test results at screening
- Positive tests for HTLV, HIV, Hepatitis B or C
- Allergy to any study drug components
- History of sarcoma or cancer within the past 5 years except certain skin cancers
- Women who are not post-menopausal (child-bearing potential)
- Pregnant or breastfeeding women
- Current drug or alcohol abuse
- Contraindications for gadolinium-enhanced MRI or unwillingness to have MRI
- Presence of fractures, bone tumours, meniscal root tear, rheumatoid arthritis, or gout based on imaging
- Investigator's judgment of unsuitability or inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oxford University Hospitals NHS Foundation Trust (Nuffield Orthopaedic Centre, Oxford)
Oxford, United Kingdom, OX3 7LD
Actively Recruiting
Research Team
S
Sarah Sorrel (CEO)
CONTACT
C
Caroline Stalla
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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