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발목의 증상 연골 또는 골다공 결절 결함이있는 17 ~ 65 세의 환자에서 MACI에 대한 연구 (MASCOT)

2026년 11월 3일 업데이트: Vericel Corporation

전향 적, 공개-라벨, 무작위, 동시 활성 제어, 종 방향, 다기관, 3 상 임상 연구, 증상 성 연골 또는 골다공증 병변이있는 환자에서 MACI의 안전성 및 효능에 대한 임상 연구 (마스코트)

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

309

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

17년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: MACI

autologous cultured chondrocytes on porcine collagen membrane
생물학적: 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.
다른: Bone Marrow Stimulation

Surgical procedure
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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]
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Vericel Corporation

수사관

  • 연구 의자: Jonathan Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB, Vericel Corporation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 28일

기본 완료 (추정된)

2030년 7월 1일

연구 완료 (추정된)

2030년 7월 1일

연구 등록 날짜

최초 제출

2025년 4월 1일

QC 기준을 충족하는 최초 제출

2025년 4월 1일

처음 게시됨 (실제)

2025년 4월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 55-2410-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다