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

NCT06459063 | Active Not Recruiting Phase 1

• 1 other identifier: 0006-24-KMC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis Thumb

Keywords

Allocetra; Cell therapy; Carpo-metacarpal; Osteoarthritis; Thumb; Macrophage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Thumb base pain - NRS

  Screening day to 12 months.

• Hand function - FIHOA

  Day 0 to 12 months.

• Key pinch and grip strength

  Day 0 to 12 months.

Study Arms (3)

Safety run-in phase - Allocetra increasing dose

OTHER

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

Randomization phase - Allocetra

ACTIVE COMPARATOR

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

Drug: Allocetra - Randomization phase

Randomization phase - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Allocetra - Safety run-in phase DRUG

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

Safety run-in phase - Allocetra increasing dose

Placebo OTHER

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

Randomization phase - Placebo

Allocetra - Randomization phase DRUG

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

Randomization phase - Allocetra

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for this clinical study must fulfill all of the following:
• Age 40 years or older.
• 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.
• Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
• X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
• Blood tests from up to three months before treatment within protocol-defined limits.

You may not qualify if:

• Subjects not eligible for this study include those that have any of the following:
• 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.
• History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
• Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
• Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
• Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
• Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.
• Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
• For women of childbearing potential, a positive pregnancy test.

Sponsors & Collaborators

• Kaplan Medical Center: lead

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

Location

Related Publications (1)

• 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.

  PMID: 8077824 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IL (1)