Osteoarthritis Thumb
Conditions
Keywords
Allocetra, Cell therapy, Carpo-metacarpal, Osteoarthritis, Thumb, Macrophage
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.
Interventions
DRUGAllocetra - Safety run-in phase
Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
OTHERPlacebo
Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
DRUGAllocetra - Randomization phase
Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
Sponsors
Kaplan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection-related reactions | Day 0 (Treatment visit). | Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation. |
| Treatment emergent adverse events | Day 0 to 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thumb base pain - NRS | Screening day to 12 months. | Thumb base pain numerical rating scale (NRS; 0-10). |
| Hand function - FIHOA | Day 0 to 12 months. | Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30). |
| Key pinch and grip strength | Day 0 to 12 months. | Key pinch and grip strength - measured with dynamometer. |
Countries
Israel
Outcome results
None listed