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Phase 1/2a randomized trial evaluating Allocetra™ intra-articular injection for the treatment of basal thumb joint (1st carpometacarpal joint) osteoarthritis

Clinicaltrials.gov ID: NCT06459063

A double blind, randomized, investigator-initiated study to evaluate the safety and efficacy of intra-articular administration of Allocetra™ compared to placebo in patients with basal thumb joint (1st carpometacarpal joint) osteoarthritis.

  • Status:
    RECRUITING
  • Age:
    40 years and older
  • Gender:
    All Genders
  • Conditions:
    Osteoarthritis Thumb

Condition

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.

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.

Assessments

  • Reactions following treatment
  • Change in basal thumb joint pain and function

Inclusion and Exclusion Criteria

Inclusion Criteria:

  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 within protocol-defined limits.

Exclusion Criteria:

  1. Any other disorder in the target thumb: 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, chondrocalcinosis in the target joint, concomitant rheumatic disease, recent intra-articular injection of steroid, hyaluronate, or other agent, into the target joint.
  2. Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
  3. Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
  4. Secondary OA such as gout, hemochromatosis or rheumatoid/psoriatic arthritis, bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.