FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis

NCT ID: NCT06690710

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2028-02-01

Brief Summary

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.

Detailed Description

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells

A single intra-articular (IA) injection of 50 million aeGF into one osteoarthritic knee

Group Type: EXPERIMENTAL

allogeneic engineered Gingival Fibroblasts (aeGF)

Intervention Type: BIOLOGICAL

single intra-articular injection of the study drug (aeGF) in the knee joint

Interventions

allogeneic engineered Gingival Fibroblasts (aeGF)

single intra-articular injection of the study drug (aeGF) in the knee joint

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TFS Trial Form Support

INDUSTRY

Sponsor Role: collaborator

Boston Imaging Core Lab

UNKNOWN

Sponsor Role: collaborator

Scarcell Therapeutics S.A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oxford University Hospitals NHS Foundation Trust (Nuffield Orthopaedic Centre, Oxford)

Oxford, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sarah Sorrel (CEO)

Role: CONTACT

sarah.sorrel@scarcell.com

+33611729481

Caroline Stalla

Role: CONTACT

caroline.stalla@scarcell.com

+33 6 46 28 78 65

Facility Contacts

Alex Shearman, MD

Role: primary

alex.shearman@ouh.nhs.uk

Other Identifiers

GF-OA-001

Identifier Type: -

Identifier Source: org_study_id