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对脚踝的症状性软骨或骨软骨缺损的17至65岁患者的MACI研究 (MASCOT)

2026年11月3日 更新者：Vericel Corporation

一项前瞻性，开放标签，随机，同时进行的主动控制，纵向，多中心，第3阶段的临床研究MACI对猫咪的症状性软骨或骨软骨病变（MASCOT）患者的安全性和有效性（MASCOT）

The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a 2-year prospective, multicenter, two-arm, parallel-group open-label clinical trial in which a total of 309 subjects, ages 17 to 65, will be randomized 2:1 to receive a 1-time treatment in the ankle with MACI or arthroscopic BMS.

After meeting screening criteria at the initial visit (Visit 1), all participants will have an index ankle arthroscopy within 8 weeks to further assess clinical trial eligibility. During the index ankle arthroscopy (Visit 2), participants will be further evaluated against entry criteria. Cartilage lesion size will be measured before randomization and any cartilage repair procedure. Only participants with at least 1 lesion ≥ 1.2 cm² on the talus will be eligible for inclusion in the clinical trial.

All participants who meet the eligibility criteria and are considered suitable for treatment in the clinical trial by their surgeon will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized 2:1 to receive either MACI or Bone Marrow Stimulation. Participants randomized to Bone Marrow Stimulation will undergo the procedure during the Visit 2 ankle arthroscopy. Subjects will be asked to follow a recommended postoperative rehabilitation program.

All biopsied tissue will be sent to the Vericel Corporation manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes, undergo cell culture expansion through at least the primary phase, and cryopreservation. Additional expansion of the cells will occur after the MACI implantation surgery has been scheduled.

Participants assigned to the MACI treatment arm will return within 5 to 12 weeks of the Visit 2 ankle arthroscopy to undergo MACI implantation procedure via arthrotomy (Visit 3). Participants will be asked to follow a recommended postoperative rehabilitation program.

All subjects will be assessed post-study treatment at Weeks 6 and 12 for safety and at Weeks 24, 36, 52, 78, and 104 for safety and efficacy. Rehabilitation status will be monitored at all post-treatment visits through Week 52.

研究类型

介入性

注册 (估计的)

309

阶段

  • 第三阶段

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

学习地点

  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85297
        • 招聘中
        • Orthopedic Specialists of North America, PLLC d/b/a OrthoArizona - South Gilbert
        • 接触：
        • 首席研究员：
          • Kipling P. Sharpe
    • California
      • Castro Valley、California、美国、94546
        • 招聘中
        • Castro Valley Care Center
        • 接触：
        • 首席研究员：
          • Deryk Jones
      • Sacramento、California、美国、95816
        • 招聘中
        • UC Davis Foot and Ankle Clinic
        • 接触：
        • 首席研究员：
          • Eric Giza, MD
    • Colorado
      • Vail、Colorado、美国、81657
        • 招聘中
        • The Steadman Clinic
        • 接触：
        • 首席研究员：
          • Jonathon Backus
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
        • 招聘中
        • MedStar Georgetown University Hospital
        • 接触：
        • 首席研究员：
          • Nicholas Casscells, MD
    • Kansas
      • Wichita、Kansas、美国、67226
        • 招聘中
        • Elevate Clinical Research Wichita
        • 首席研究员：
          • Jon Morgan, MD
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
        • 接触：
        • 首席研究员：
          • Kyle R Duchman
    • North Carolina
      • Durham、North Carolina、美国、27705
        • 招聘中
        • Duke Orthopaedic Surgery
        • 接触：
        • 首席研究员：
          • Annunziato Amendola, MD
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15203
        • 招聘中
        • University of Pittsburgh Medical Center Freddie Fu Sports Medicine Center
        • 接触：
        • 首席研究员：
          • Ting Cong
    • Texas
      • Houston、Texas、美国、77058
        • 招聘中
        • Elevate Clinical Research
        • 首席研究员：
          • Jesus Juarez, MD
        • 接触：
      • San Antonio、Texas、美国、78251
        • 招聘中
        • Rodaro, LLC
        • 首席研究员：
          • Robert Farber, MD
        • 接触：
    • Virginia
      • Charlottesville、Virginia、美国、22903
        • 招聘中
        • UVA Orthopedic Center Ivy Road
        • 接触：
        • 首席研究员：
          • Minton Truitt Cooper, MD

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

17年 至 65年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 17 to 65 at the time of planned randomization visit (Visit 2).
  2. One or more symptomatic chondral or osteochondral lesion/s as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.
  3. International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion/s located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.
  4. At least 1 lesion ≥ 1.2 cm².
  5. Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.
  6. Participant will refrain from using Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 12 weeks post-study treatment. (Post-surgical use of low-dose aspirin for clot prevention is acceptable).
  7. Participant will restrict pain medication to over-the-counter analgesics (NSAIDs or acetaminophen/paracetamol) after 12 weeks post-study treatment.
  8. Participant must have Hematocrit ≥30.0%; White Blood Cell count ≤14,000 cells/μL; Platelet Count ≥50,000 platelets/μL; Creatinine ≤2.0 mg/dL; and International Normalized Ratio (INR) ≤1.6.

Exclusion Criteria:

  1. Lesions with an underlying bony defect depth of > 5 mm.

  2. Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).

  3. Previous investigational drug, biologic or device use within 12 weeks prior to Visit.

  4. Avascular necrosis of the target ankle.

  5. Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.

  6. Participant with "kissing lesions" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.

  7. Participant with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).

  8. Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).

  9. History of advanced or severe osteoarthritis of the ankle as determined by prior surgical history confirming no joint space (i.e., "bone on bone") or radiographic evidence of Modified Kellgren-Lawrence Grade 4 arthritis (i.e., osteophytes on lateral and medial malleoli and at the tibiotalar joint margins, narrowing of the joint space width > 50%, and tibiotalar sclerosis), Van Dijk Grade III (i.e., total or subtotal destruction of the joint space) or the equivalent.

  10. Known history of septic arthritis in the target ankle joint within 1 year prior to Visit 1.

  11. Current malignancy or treatment for malignancy within the past 5 years prior to Visit 1, excluding non-melanoma skin cancer.

  12. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.

  13. Females who are pregnant or lactating.

  14. Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:

    1. Any condition that has potential for negatively impacting intra- or postoperative course (e.g., uncontrolled diabetes, heavy smoking). - Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8.0% and/or fasting plasma glucose >250 mg/dL (13.9 mmol/L) within the last 90 days prior to Screening Visit 1 - Heavy smoking is defined as current smoker with use of ≥20 cigarettes per day (≥1 pack/day) at the time of Screening Visit 1.
    2. Conditions that limit compliance with rehabilitation program.
    3. Any condition that has potential for significantly limiting participant's ability to assess postoperative ankle function.
    4. Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the clinical trial.
    5. Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance.
    6. Any abnormal screening blood work that the Investigator deems clinically significant in addition to the parameters delineated in Inclusion Criterion #8.

  15. Injection of hyaluronic acid (HA), platelet-rich plasma (PRP), and/or corticosteroids in the target ankle within 90 days prior to Visit 1.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MACI

autologous cultured chondrocytes on porcine collagen membrane
生物：autologous cultured chondrocytes on porcine collagen membrane

An autologous cellularized scaffold combination product being studied for the repair of symptomatic, single or multiple full-thickness cartilage defects of the talus with or without bone involvement in adults.
其他：Bone Marrow Stimulation

Surgical procedure
程序：Bone Marrow Stimulation

A surgical awl or microdrill will be used to make multiple holes in the exposed base of the lesion. The microfracture procedure should result in holes that are approximately 3 to 4 mm apart.

When fat droplets can be seen coming from the marrow cavity, the appropriate depth (approximately 2 to 4 mm) has been reached.

The released marrow elements (including mesenchymal stem cells, growth factors, and other healing proteins) form a surgically induced clot that provides an enriched environment for new tissue formation.

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
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores
大体时间：Baseline to Week 104

The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.

Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.
Baseline to Week 104

次要结果测量

结果测量
措施说明
大体时间
Percentage of participants who respond to study treatment after 2 years, i.e., participants who have ≥ 10-point improvement on both the FAOS Pain and Function (SRA) subscale scores from Baseline to Week 104.
大体时间：Baseline to Week 104

The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.
Baseline to Week 104
Change from Baseline to Week 104 in the remaining FAOS subscales scores [Symptoms, Function (Daily Living) and Quality of Life]
大体时间：Baseline to Week 104

The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms.
Baseline to Week 104

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

Vericel Corporation

调查人员

  • 学习椅：Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB、Vericel Corporation

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28日

初级完成 (估计的)

2030年7月1日

研究完成 (估计的)

2030年7月1日

研究注册日期

首次提交

2025年4月1日

首先提交符合 QC 标准的

2025年4月1日

首次发布 (实际的)

2025年4月8日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11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

  • 55-2410-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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