Osteoarthritis, KneePhase 1NCT06690710
FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis
A Phase 1 study testing allogeneic engineered Gingival Fibroblasts (aeGF) in people with Osteoarthritis, Knee, run by Scarcell Therapeutics S.A.S. at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- allogeneic engineered Gingival Fibroblasts (aeGF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2025to 1 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Hypersensitivity to any of the IMP components or excipients;
- History of sarcoma;
- History of cancer within five years, except treated basal cell and squamous cell carcinoma of the skin;
- Women of child-bearing potential, i.e., not post-menopausal (see Section 8.4.5)
- Women who are pregnant or breastfeeding;
- Current drug or alcohol abuse;
- 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;
- 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;
- Participants who, in the Investigator's opinion, are unsuitable or unlikely to comply with the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust (Nuffield Orthopaedic Centre, Oxford)
Oxford, OX3 7LD
Alex Shearman, MD, alex.shearman@ouh.nhs.uk
About this study
Official title: 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
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.
Read the 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
- Being tested
- allogeneic engineered Gingival Fibroblasts (aeGF)
- Keywords
- phase 1, osteoarthritis, knee, cell therapy, ATMP, Advanced Therapy Medicinal Product, Gingival Fibroblasts
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic engineered Gingival Fibroblasts (aeGF)Biological
single intra-articular injection of the study drug (aeGF) in the knee joint
| Study group | Role | What they receive |
|---|---|---|
| allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells | Experimental | A single intra-articular (IA) injection of 50 million aeGF into one osteoarthritic knee Receives: Biological: allogeneic engineered Gingival Fibroblasts (aeGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months
Secondary outcomes (6)
Change in knee pain and function as assessed by KOOS questionnaire
KOOS is a self-reported patient outcome measure used to assess pain, function, quality of life, and ADL. 42 items are grouped into 5 subscales, i.e.: pain; other symptoms; function in daily living (ADL); Function in Sport and Recreation (Sport/Rec); and, knee-related quality of life. The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems.
Measured: 1, 3, 6, 12 and 24 months assessments will be compared with baseline
Change in cartilage thickness as assessed by quantitative MRI
Cartilage change will be assessed using the semi-quantitative MRI Osteoarthritis Knee Score (MOAKS) system which is a two-digit score of area size and percentage of subregion affected by full thickness cartilage loss. MOAKS scores articular cartilage in 14 subregions across the knee in 2 dimensions: area of loss as % of subregion surface (AREA); and % of subregion that has full-thickness loss (FTL). AREA and FTL are scored as 0: None; 1: < 10%; 2: 10-75%; 3: >75%.
Measured: Assessed at 12 months and compared with baseline
Change from baseline in biomarker CRP levels
Blood samples will be collected for biomarker, i.e. CRP analysis. CRP will be measured using a standard assay per local laboratory practice.
Measured: Results at 1, 3 and 12 months will be compared with baseline
Use of rescue analgesic medication
Recording of rescue medication
Measured: 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)
Change will be assessed through a contrast enhanced MRI evaluation measuring the level of synovitis in the knee-joint. Inflammation will be measured on an 11-point synovitis score; a reduction by 2 points indicates an improvement.
Measured: At 6 months and compared with baseline
Incidence, relatedness, severity and duration of TEAEs at 24 months
The safety of aeGF will be defined by incidence, relatedness, severity and duration of TEAEs at 24 months. The incidence (number and percentage) of participants reporting TEAEs within 24 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.
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start14 Aug 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First in Human, single (expected therapeutic) dose study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scarcell Therapeutics S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support, Boston Imaging Core Lab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690710
- Sponsor's protocol ID
- GF-OA-001
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06690710
- Acronym / sponsor ID
- GF-OA-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- phase 1, osteoarthritis, knee, cell therapy, ATMP, Advanced Therapy Medicinal Product, Gingival Fibroblasts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Scarcell Therapeutics S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support, Boston Imaging Core Lab
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First in Human, single (expected therapeutic) dose study
| Arm | Type | Receives |
|---|---|---|
| allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells | Experimental | Biological: allogeneic engineered Gingival Fibroblasts (aeGF)A single intra-articular (IA) injection of 50 million aeGF into one osteoarthritic knee |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Score ≥3 on visual analogue scale (VAS) (0-10 range) for pain at Screening.
Key exclusion criteria (24 listed)
- Grade 0, 1 or 4 on the Kellgren-Lawrence grading scale for the target knee:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic engineered Gingival Fibroblasts (aeGF)single intra-articular injection of the study drug (aeGF) in the knee joint | Biological | allogeneic engineered Gingival Fibroblasts (aeGF), 50 million cells |
Primary outcome
The safety of a single IA injection of aeGF assessed by treatment-emergent adverse events (TEAEs) at 3 months
Time frame: 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.
6 secondary outcomes
Change in knee pain and function as assessed by KOOS questionnaire
Time frame: 1, 3, 6, 12 and 24 months assessments will be compared with baseline
Change in cartilage thickness as assessed by quantitative MRI
Time frame: Assessed at 12 months and compared with baseline
Change from baseline in biomarker CRP levels
Time frame: Results at 1, 3 and 12 months will be compared with baseline
Use of rescue analgesic medication
Time frame: 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)
Time frame: At 6 months and compared with baseline
Incidence, relatedness, severity and duration of TEAEs at 24 months
Time frame: At 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic engineered Gingival Fibroblasts (aeGF) in people with Osteoarthritis, Knee, run by Scarcell Therapeutics S.A.S. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Sorrel (CEO) (+33611729481, sarah.sorrel@scarcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of a single IA injection of aeGF assessed by treatment-emergent adverse events (TEAEs) at 3 months (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.