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

NCT06690710 | Recruiting Phase 1

• 1 other identifier: GF-OA-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

phase 1; osteoarthritis; knee; cell therapy; ATMP; Advanced Therapy Medicinal Product; Gingival Fibroblasts

Outcome Measures

Primary Outcomes (1)

• 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.

  At 3 months

Secondary Outcomes (6)

• Change in knee pain and function as assessed by KOOS questionnaire

  1, 3, 6, 12 and 24 months assessments will be compared with baseline

• Change in cartilage thickness as assessed by quantitative MRI

  Assessed at 12 months and compared with baseline

• Change from baseline in biomarker CRP levels

  Results at 1, 3 and 12 months will be compared with baseline

• Use of rescue analgesic medication

  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)

  At 6 months and compared with baseline

Study Arms (1)

allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells

EXPERIMENTAL

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

Biological: allogeneic engineered Gingival Fibroblasts (aeGF)

Interventions

allogeneic engineered Gingival Fibroblasts (aeGF) BIOLOGICAL

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

allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• Male or female participants aged ≥40 years;
• Evidence of OA in the medial tibiofemoral joint (MTJ) as follows:
• Clinical - knee pain;
• Radiological - Kellgren-Lawrence:
• Grade 2 - definite osteophytes, possible joint space narrowing (JSN), or;
• Grade 3 - moderate osteophytes, definite JSN, some sclerosis, possible bone-end deformity (Altman et al., 1986; Kellgren et al., 1957; Kohn et al., 2016).
• Minimal joint space width (JSW) of 2.5 mm on knee X-ray (OARSI 1 or 2);
• Score ≥3 on visual analogue scale (VAS) (0-10 range) for pain at Screening.

You may not qualify if:

• 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;
• Severe malalignment of \>10° varus or valgus.
• 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;
• 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;
• Taking corticosteroids or any immunosuppressants, e.g., cyclosporine, prior to Screening;
• IA treatment with steroids or hyaluronic acid derivatives in the 3 months before Day 1;
• Planned major surgery, e.g., joint replacement, within 2 months after IA injection;
• Previous surgery on the target knee including diagnostic arthroscopy;
• 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;
• Any known active infection;
• 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;
• Positive result for HTLV, HIV, Hepatitis B or C;

Sponsors & Collaborators

• Scarcell Therapeutics S.A.S.: lead
• TFS Trial Form Support: collaborator
• Boston Imaging Core Lab: collaborator

Study Sites (1)

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

Oxford, OX3 7LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Sarah Sorrel (CEO)

CONTACT

+33611729481; sarah.sorrel@scarcell.com

Caroline Stalla

CONTACT

+33 6 46 28 78 65; caroline.stalla@scarcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First in Human, single (expected therapeutic) dose study

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: August 14, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)