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Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

2026年8月24日 更新者：Enlivex Therapeutics Ltd.

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

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).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

270

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 丹麦
      • Gandrup、丹麦、9362
        • 招聘中
        • Sanos Clinic Gandrup
        • 接触：
        • 首席研究员：
          • Søren R Bro, MD
      • Herlev、丹麦、2730
        • 招聘中
        • Sanos Clinic Herlev
        • 接触：
        • 首席研究员：
          • Linda Bracher, MD
      • Vejle、丹麦、7100
        • 招聘中
        • Sanos Clinic Vejle
        • 接触：
        • 首席研究员：
          • Sidsel Boll, MD
  • 波兰
      • Bytom、波兰、41-902
        • 尚未招聘
        • NZOZ Bif-Med. s.c
        • 接触：
        • 首席研究员：
          • Hanna Mastalerz, MD
      • Katowice、波兰、40-748
      • Krakow、波兰、30-363
        • 尚未招聘
        • Centrum Medyczne Plejady
        • 接触：
        • 首席研究员：
          • Alicja Włoch, MD
      • Poznan、波兰、60-218
        • 招聘中
        • Medyczne Centrum Hetmańska
        • 接触：
        • 首席研究员：
          • Piotr Leszczyński, MD
      • Poznan、波兰、60-446
        • 尚未招聘
        • Reumedika sp. z o.o.
        • 接触：
        • 首席研究员：
          • Wieslawa Porawska, MD
      • Radom、波兰、26-610
        • 尚未招聘
        • DC-MED Michal Kowalski S.K. Radom
        • 接触：
        • 首席研究员：
          • Tomasz Romaniuk, MD
      • Swidnica、波兰、58-100
        • 招聘中
        • DC-MED Michal Kowalski S.K. Swidnica
        • 接触：
        • 首席研究员：
          • Paweł Michalec, MD
      • Warsaw、波兰、02-677
        • 招聘中
        • ETG Warszawa
        • 接触：
        • 首席研究员：
          • Radoslaw Gorski, MD
      • Warsaw、波兰、01-696
        • 尚未招聘
        • ETG JustMed
        • 接触：
        • 首席研究员：
          • Wojciech Zakiewicz, MD
      • Wroclaw、波兰、52-210
        • 尚未招聘
        • Migre Polskie Centrum
        • 接触：
        • 首席研究员：
          • Marta Wasilewska, MD
  • 美国
    • Florida
      • Longwood、Florida、美国、32750
        • 招聘中
        • Future Medical Research
        • 接触：
        • 首席研究员：
          • Mayra Abreu, MD
      • Miami、Florida、美国、33166
        • 招聘中
        • South Florida Research Phase I-IV
        • 接触：
        • 首席研究员：
          • Eduardo Viera, MD
    • Louisiana
      • New Orleans、Louisiana、美国、70115
        • 招聘中
        • DelRicht Research @ Touro Medical Center
        • 首席研究员：
          • Patrick Dennis, MD
        • 接触：
    • Michigan
      • Troy、Michigan、美国、48085

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

  1. Age 64 years or above.
  2. Diagnosis of primary femorotibial knee OA.
  3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
  4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
  5. Index knee pain assessed during the screening period and following wash-out of pain medications.
  6. Willingness to abstain from prohibited medications/treatments during the trial.
  7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  8. 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.

Exclusion Criteria:

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

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Allocetra
Three intra-articular injections of Allocetra at a selected dose, into the index knee.
药品：Allocetra
Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
安慰剂比较：Placebo
Three intra-articular injections of placebo into the index knee.
其他：安慰剂
本研究中使用的对照将是安慰剂。 安慰剂溶液含有除 Allocetra 细胞外的所有赋形剂。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months
大体时间：3 months.
The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
3 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months
大体时间：3 months.
The change from baseline for the WOMAC Function score at 3 months between Allocetra and Placebo. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
3 months.
Primary Safety Endpoint
大体时间：Day 0 to 6 months.
Incidence and severity of Adverse Events (AEs) up to 6 months. AE incidence will be represented as % per study group and AE severity will be represented as mild, moderate or severe.
Day 0 to 6 months.

次要结果测量

结果测量
措施说明
大体时间
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score
大体时间：6 months.
The change from baseline of the WOMAC Pain score at 6 months. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
6 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score
大体时间：6 months.
The change from baseline of the WOMAC Function score at 6 months. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
6 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score
大体时间：3 months, 6 months.
The change from baseline for the WOMAC Total score at 3 and 6 months. Total score ranges from 0 to 240 when higher score means worse outcomes.
3 months, 6 months.
Average Daily Pain Numerical Rating Scale (ADP-NRS)
大体时间：3 months, 6 months.
The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 and 6 months. ADP-NRS score ranges from 0 (No pain) to 10 (Worst imaginable pain).
3 months, 6 months.
Outcome Measures in Rheumatology and Osteoarthritis Research Society International (OMERACT-OARSI) score
大体时间：3 months, 6 months.
Treatment responders at 3 and 6 months according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria. OMERACT-OARSI score will be represented as % when higher scores means a better outcome.
3 months, 6 months.
Euro Quality of Life-5-Dimension (EQ-5D) index scores
大体时间：3 months, 6 months.
Change from baseline in Euro Quality of Life-5-Dimension (EQ-5D) index scores at 3 and 6 months. EQ-5D index scores in composed of an index value which range from 0 to 1 and EQ VAS score which range from 0 to 100. In both a higher score means better outcomes.
3 months, 6 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Enlivex Therapeutics Ltd.

合作者

Nordic Bioscience Clinical Development (NBCD)

调查人员

  • 研究主任：Lital Weinfeld Bergman、Senior Director of Clinical Operations

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ENX-CL-05-002

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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