Temporomandibular Joint OsteoarthritisPhase 1NCT06748651
Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)
A Phase 1 study testing Allocetra in people with Temporomandibular Joint Osteoarthritis, run by Dr. Amit Druyan at 1 site in Israel.
Trial summary
This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Osteoarthritis
- What is being tested?
- Allocetra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2024to 8 Apr 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with temporomandibular OA in the target TMJ.
- Inflammatory findings by Magnetic Resonance Imaging (MRI).
- Acceptable blood workup results (CBC, electrolytes, kidney and liver function).
Who cannot join
- Prior intra-articular injection to the target TMJ within 3 months prior to treatment.
- Any significant injury or surgery to the target TMJ.
- Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body.
- Patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Amit Druyan, MD, +972-52-3359665, amit.druyan@sheba.health.gov.il
Amit Druyan, MD
About this study
Official title: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)
This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)
Read the detailed description
The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies.
The study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint.
Patients will be followed for up to a year following treatment.
- Conditions
- Temporomandibular Joint Osteoarthritis
- Being tested
- Allocetra
- Keywords
- ALLOCETRA, Temporomandibular, Osteoarthritis, TMJ, Macrophages, Cell therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllocetraDrug
Intra-articular injection of Allocetra performed once on Day 1 of the study
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Injection of Allocetra performed once on Day 1 of the study | Experimental | Not described Receives: Drug: Allocetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of AEs, SAEs and injection reactions following treatment
Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Measured: Day 0 to 12 month
Secondary outcomes (1)
Patient reported pain in the target TMJ
Change from baseline in patient reported pain Numerical Rating Scale (NRS) in the target TMJ at 3 months and 6 months following treatment.
Measured: Screening to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Dec 2024
- Primary completion7 Feb 2026 (estimated)
- Study completion8 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint OsteoarthritisStudies 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
- The study will consist of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint .
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Amit Druyan
- Sponsor type
- Other government
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor-investigator, Dr. Amit Druyan, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748651
- Sponsor's protocol ID
- 1400-24-SMC
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)
- ClinicalTrials.gov ID
- NCT06748651
- Acronym / sponsor ID
- 1400-24-SMC
- Conditions
- Temporomandibular Joint Osteoarthritis
- Keywords
- ALLOCETRA, Temporomandibular, Osteoarthritis, TMJ, Macrophages, Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Dr. Amit DruyanOther government
- Collaborators
- Sheba Medical Center
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 8 Apr 2026 (estimated)
- First posted
- 27 Dec 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.
This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)
Detailed description
The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies.
The study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint.
Patients will be followed for up to a year following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will consist of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint .
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Injection of Allocetra performed once on Day 1 of the study | Experimental | Drug: Allocetra |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with temporomandibular OA in the target TMJ.
- Inflammatory findings by Magnetic Resonance Imaging (MRI).
- Acceptable blood workup results (CBC, electrolytes, kidney and liver function).
Key exclusion criteria (4 listed)
- Prior intra-articular injection to the target TMJ within 3 months prior to treatment.
- Any significant injury or surgery to the target TMJ.
- Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body.
- Patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.
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 |
|---|---|---|
| AllocetraIntra-articular injection of Allocetra performed once on Day 1 of the study | Drug | Intra-articular Injection of Allocetra performed once on Day 1 of the study |
Primary outcome
Number and severity of AEs, SAEs and injection reactions following treatment
Time frame: Day 0 to 12 month
Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
1 secondary outcome
Patient reported pain in the target TMJ
Time frame: Screening to 6 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 27 Dec 2024.
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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 Allocetra in people with Temporomandibular Joint Osteoarthritis, run by Dr. Amit Druyan at 1 site in Israel.
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 3 inclusion and 4 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 27 Dec 2024. 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 Israel. 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 Amit Druyan, Dr. (972-3-5304413, Amit.Druyan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of AEs, SAEs and injection reactions following treatment (time frame: Day 0 to 12 month). 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 27 Dec 2024.