Single knee injection of donor-engineered gum cells for moderate knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Scarcell Therapeutics is testing an allogeneic engineered Gingival Fibroblast (aeGF) product made from donor gum tissue as a tissue-engineered product intended to reduce inflammation and support cartilage repair in knee osteoarthritis. This Phase 1, first-in-human trial will deliver one ultrasound-guided intra-articular injection of aeGF to 15 participants with medial tibiofemoral OA (Kellgren-Lawrence grade 2–3). Participants will complete a screening visit, receive the injection, have a safety phone check within a week, and attend clinic follow-up visits with imaging and symptom assessments at 1, 3, 6, 12, and 24 months. Preclinical animal studies demonstrated anti-inflammatory, analgesic, and cartilage-regenerating effects that supported moving to a human safety trial.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Willing and able to provide informed consent;
2. Male or female participants aged ≥40 years;
3. Evidence of OA in the medial tibiofemoral joint (MTJ) as follows:

   * Clinical - knee pain;
   * Radiological - Kellgren-Lawrence:

     1. Grade 2 - definite osteophytes, possible joint space narrowing (JSN), or;
     2. Grade 3 - moderate osteophytes, definite JSN, some sclerosis, possible bone-end deformity (Altman et al., 1986; Kellgren et al., 1957; Kohn et al., 2016).
     3. Minimal joint space width (JSW) of 2.5 mm on knee X-ray (OARSI 1 or 2);
4. Score ≥3 on visual analogue scale (VAS) (0-10 range) for pain at Screening.

Exclusion Criteria:

1. Grade 0, 1 or 4 on the Kellgren-Lawrence grading scale for the target knee:

   * Grade 0: No osteophyte or JSN;
   * Grade 1: Doubtful JSN and possible osteophytic lipping;
   * Grade 4: Large osteophytes, 'bone-on-bone' JSN, severe sclerosis, and definite deformity of bone ends;
2. Severe malalignment of \>10° varus or valgus.
3. OA secondary to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, neuropathic arthropathy, trauma, rheumatoid arthritis, gout, psoriatic arthritis, autoimmune arthritis or spondylitis;
4. Receipt of any investigational medicinal product (IMP) or any experimental therapeutic procedure in the 3 months or 5 half-lives before Screening, whichever is longer;
5. Taking corticosteroids or any immunosuppressants, e.g., cyclosporine, prior to Screening;
6. IA treatment with steroids or hyaluronic acid derivatives in the 3 months before Day 1;
7. Planned major surgery, e.g., joint replacement, within 2 months after IA injection;
8. Previous surgery on the target knee including diagnostic arthroscopy;
9. Lesions at the planned injection site that would present a contraindication to local injection of the study drug, e.g., open wounds, psoriatic lesions or infections of the skin;
10. Any known active infection;
11. Clinically significant abnormal haematology or biochemistry values (platelets, haemoglobin, white blood cells, alkaline phosphatase, AST, ALT, blood creatinine, bilirubin) or coagulation (PT, PTT) at Screening;
12. Positive result for HTLV, HIV, Hepatitis B or C;
13. Hypersensitivity to any of the IMP components or excipients;
14. History of sarcoma;
15. History of cancer within five years, except treated basal cell and squamous cell carcinoma of the skin;
16. Women of child-bearing potential, i.e., not post-menopausal (see Section 8.4.5)
17. Women who are pregnant or breastfeeding;
18. Current drug or alcohol abuse;
19. Contraindication to receiving a gadolinium contrast-enhanced magnetic resonance imaging (MRI) of the target knee (metallic implants, claustrophobia, previous anaphylactic reaction to gadolinium, eGFR1 \<30 mL/min/1.73 m2, acutely deteriorating renal function) or is unwilling to have MRI performed;
20. Participants with subchondral insufficiency fracture, osteonecrosis, acute or subacute fracture, acute bone contusion, pathologic fracture, stress fracture, fragmentation of articular bone, bone or soft tissue tumour, bone marrow infiltration, posterior meniscal root tear, rheumatoid arthritis, gout based on X-ray or MRI reading;
21. Participants who, in the Investigator's opinion, are unsuitable or unlikely to comply with the study procedures.

Where it's running

• Oxford University Hospitals NHS Foundation Trust (Nuffield Orthopaedic Centre, Oxford)
  Oxford, United Kingdom Recruiting

Study contacts

• Study coordinator: Sarah Sorrel (CEO)
• Email: sarah.sorrel@scarcell.com
• Phone: +33611729481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.