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

Osteoarthritis Thumb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459063
• Other study ID #: 0006-24-KMC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 10, 2024
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: Kaplan Medical Center
• Contact: Amir Oron, MD
• Phone: +972-54-2427072
• Email: amiroro[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: November 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Thumb

Intervention

Drug:
• Allocetra - Safety run-in phase
Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.

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

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.

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection-related reactions	Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.	Day 0 (Treatment visit).
Primary	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	Thumb base pain - NRS	Thumb base pain numerical rating scale (NRS; 0-10).	Screening day to 12 months.
Secondary	Hand function - FIHOA	Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30).	Day 0 to 12 months.
Secondary	Key pinch and grip strength	Key pinch and grip strength - measured with dynamometer.	Day 0 to 12 months.