Single knee injection of donor-engineered gum cells for moderate knee osteoarthritis
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
This will try a single injection of donor-derived engineered gingival fibroblasts into the knee to see if it is safe and helps people aged 40+ with moderate knee osteoarthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Scarcell Therapeutics S.A.S. Industry-sponsored |
| Locations | 1 site (Oxford) |
| Trial ID | NCT06690710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older with symptomatic medial tibiofemoral knee osteoarthritis (Kellgren-Lawrence grade 2 or 3), minimum joint space width around 2.5 mm, and pain ≥3 on a 0–10 VAS who can attend follow-up visits in Oxford.
Not a fit: Patients with very early (KL 0–1) or end-stage (KL 4) disease, severe malalignment (>10° varus), or other exclusion criteria are unlikely to benefit from this single-injection safety study.
Why it matters
Potential benefit: If successful, the treatment could reduce knee pain and inflammation and promote cartilage repair, potentially delaying the need for joint replacement.
How similar studies have performed: Similar engineered cell or stromal therapies have shown promise in animal models and limited early clinical work, but this is the first human trial of aeGF specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oxford
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.