Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

NCT ID: NCT06459063

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2025-11-30

Brief Summary

This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).

Detailed Description

Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.

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 safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.

The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint.

Patients will be followed for up to a year following treatment.

Conditions

Osteoarthritis Thumb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Safety run-in phase - Allocetra increasing dose

A dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase.

Group Type: OTHER

Allocetra - Safety run-in phase

Intervention Type: DRUG

Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.

Randomization phase - Allocetra

Injection of Allocetra to the 1st CMC joint in the target thumb.

Group Type: ACTIVE_COMPARATOR

Allocetra - Randomization phase

Intervention Type: DRUG

Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.

Randomization phase - Placebo

Injection of placebo to the 1st CMC joint in the target thumb.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.

Interventions

Allocetra - Safety run-in phase

Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.

Intervention Type: DRUG

Placebo

Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.

Intervention Type: OTHER

Allocetra - Randomization phase

Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects eligible for this clinical study must fulfill all of the following:

1. Age 40 years or older.

2. Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.

3. Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).

4. X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.

5. Blood tests from up to three months before treatment within protocol-defined limits.

Exclusion Criteria

Subjects not eligible for this study include those that have any of the following:

1. Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand.

2. History of chondrocalcinosis in the target joint, concomitant rheumatic disease.

3. Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.

4. Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.

5. Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).

6. Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.

7. Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.

8. For women of childbearing potential, a positive pregnancy test.

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

Sponsors

Kaplan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amir Oron

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaplan Medical Center

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Amir Oron, MD

Role: CONTACT

amiroro@clalit.org.il

+972-54-2427072

Shiran Rogoff

Role: CONTACT

Shiranro1@clalit.org.il

+972-52-6804062

Facility Contacts

Shiran Rogoff

Role: primary

shiranro1@clalit.org.il

References

Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg Br. 1994 Jun;19(3):340-1. doi: 10.1016/0266-7681(94)90085-x.

Reference Type: BACKGROUND

PMID: 8077824 (View on PubMed)

Other Identifiers

0006-24-KMC

Identifier Type: -

Identifier Source: org_study_id