Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)

NCT06748651 | Recruiting Phase 1

• 1 other identifier: 1400-24-SMC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Temporomandibular Joint Osteoarthritis

Keywords

ALLOCETRA; Temporomandibular; Osteoarthritis; TMJ; Macrophages; Cell therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 to 12 month

Secondary Outcomes (1)

• Patient reported pain in the target TMJ

  Screening to 6 months

Other Outcomes (1)

• Exploratory outcome: Assessment of TMJ function by examination

  Screening to 12 months

Study Arms (1)

Intra-articular Injection of Allocetra performed once on Day 1 of the study

EXPERIMENTAL

Drug: Allocetra

Interventions

Allocetra DRUG

Intra-articular injection of Allocetra performed once on Day 1 of the study

Intra-articular Injection of Allocetra performed once on Day 1 of the study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Amit Druyan: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Amit Druyan, Dr.

CONTACT

972-3-5304413; Amit.Druyan@sheba.health.gov.il

Tehila Biton

CONTACT

972-3-5304413; tehila.biton@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 .

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: December 15, 2024
• Primary Completion: February 7, 2026
• Study Completion: April 8, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

IL (1)