Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

Официальное название

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

Обзор

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).

Подробное описание

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.

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.

The main goal of this Phase IIb clinical trial is to evaluate the efficacy of intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA), in comparison to Placebo (a look-alike substance that contains no drug). Participants will be randomized 1:1 to Allocetra or Placebo. Treatment consists of a total of three ultrasound-guided intra-articular (IA) injections (Days 0, 14, 28). Follow-up will continue for 12 months.

Вмешательства

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

Первичные конечные точки

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months [Срок оценки: 3 months.]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months [Срок оценки: 3 months.]
• Primary Safety Endpoint [Срок оценки: Day 0 to 6 months.]

Вторичные конечные точки (6)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score [Срок оценки: 6 months.]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score [Срок оценки: 6 months.]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score [Срок оценки: 3 months, 6 months.]
• Average Daily Pain Numerical Rating Scale (ADP-NRS) [Срок оценки: 3 months, 6 months.]
• Outcome Measures in Rheumatology and Osteoarthritis Research Society International (OMERACT-OARSI) score [Срок оценки: 3 months, 6 months.]
• Euro Quality of Life-5-Dimension (EQ-5D) index scores [Срок оценки: 3 months, 6 months.]

Критерии участия

Критерии включения

Participants must meet all of the inclusion criteria listed below to be eligible for the study:

• Age 64 years or above.
• Diagnosis of primary femorotibial knee OA.
• Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
• Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
• Index knee pain assessed during the screening period and following wash-out of pain medications.
• Willingness to abstain from prohibited medications/treatments during the trial.
• Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

Критерии исключения

Participants will be excluded from the study if they meet any of the following criteria:

• Severe or end-stage osteoarthritis of the index knee.
• Clinically significant structural abnormalities or instability of the index knee.
• Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
• Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
• Any known history of inflammatory arthropathy or crystal-deposition disease.
• Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
• Clinically significant widespread pain syndromes.
• Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
• Body Mass Index (BMI) >40 kg/m²
• Use of medications that may interfere with pain assessment or study outcomes.
• Known coagulopathy or use of anticoagulant/antiaggregant medication.
• Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Польша · 10 центров

• NZOZ Bif-Med. s.c — Bytom
• Vita Longa Sp. z o.o. — Katowice
• Centrum Medyczne PLEJADY — Krakow
• Medyczne Centrum Hetmańska — Poznan
• Reumedika sp. z o.o. — Poznan
• DC-MED Michal Kowalski S.K. Radom — Radom
• DC-MED Michal Kowalski S.K. Swidnica — Swidnica
• Etg Justmed — Warsaw
• … и ещё 2 центра

США · 4 центра

• Future Medical Research — Longwood
• South Florida Research Phase I-IV — Miami
• DelRicht Research @ Touro Medical Center — New Orleans
• Oakland Medical Research — Troy

Дания · 3 центра

• Sanos Clinic Gandrup — Gandrup
• Sanos Clinic Herlev — Herlev
• Sanos Clinic Vejle — Vejle

Идентификаторы

NCT: NCT07580716 · ENX-CL-05-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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