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

A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis Thumb
• Intervention / Treatment: Drug: Allocetra - Safety run-in phase; Drug: Allocetra - Randomization phase; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Rehovot, Israel
    • Kaplan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Allocetra - Safety run-in phase; Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
Active Comparator: Randomization phase - Allocetra; Injection of Allocetra to the 1st CMC joint in the target thumb.	Drug: Allocetra - Randomization phase; Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
Placebo Comparator: Randomization phase - Placebo; Injection of placebo to the 1st CMC joint in the target thumb.	Other: Placebo; Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection-related reactions	Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.	Day 0 (Treatment visit).
Treatment emergent adverse events	Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.	Day 0 to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thumb base pain - NRS	Thumb base pain numerical rating scale (NRS; 0-10).	Screening day to 12 months.
Hand function - FIHOA	Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30).	Day 0 to 12 months.
Key pinch and grip strength	Key pinch and grip strength - measured with dynamometer.	Day 0 to 12 months.

Collaborators and Investigators

• Sponsor: Kaplan Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Cell therapy; Thumb; Macrophage; Allocetra; Carpo-metacarpal
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 0006-24-KMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No