Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

Conditions

• Primary Knee Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

64 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allocetra — DRUG
  Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
• Placebo — OTHER
  The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).

Key Dates

Start date

May 1, 2026

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2028

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Allocetra
  Three intra-articular injections of Allocetra at a selected dose, into the index knee.
• Placebo Comparator: Placebo
  Three intra-articular injections of placebo into the index knee.

Primary Outcome Measure

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months [ Time Frame: 3 months. ]

Central Contacts

• Lior Binder
  +972-54-8054599
  [email protected]
• Lital Weinfeld Bergman
  [email protected]

Locations (4)

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