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Allocetra™ intra-articular injection for the treatment of end stage knee osteoarthritis

Clinicaltrials.gov ID: NCT06208241

An investigator-initiated study to evaluate the safety and responses to intra-articular administration of Allocetra™ in patients with end-stage knee osteoarthritis.

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

Condition

Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.

This study is assessing the safety and efficacy of Allocetra™ in patients suffering from end-stage knee osteoarthritis, who are indicated for total knee replacement surgery.

Assessments

  • Reactions following treatment
  • Change in knee pain and function

Inclusion and Exclusion Criteria

Inclusion Criteria:

  1. Age 18 or older.
  2. Patients diagnosed with end-stage knee osteoarthritis with pain and functional disability from osteoarthritis, who are scheduled for or offered knee replacement surgery.
  3. X-ray positive for knee osteoarthritis.
  4. Acceptable blood workup results as defined in the protocol.

Exclusion Criteria:

  1. Any other disorder in the target knee: active local infection in the vicinity of the knee joint, previous surgery of total or partial knee replacement.
  2. Patients with a major medical condition, acute infection, other limb pain arising from a different or unknown origin. neurological disease or rheumatic condition, bleeding disorders, cognitive disorder.