MACI for Chondral Defects

(MASCOT Trial)

Overseen By Vericel Clinical Affairs

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Vericel Corporation

Must not be taking: Aminoglycosides

Disqualifiers: Avascular necrosis, Rheumatoid arthritis, Osteoarthritis, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 5-12 weeks

309 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MACI, a type of cell therapy, for individuals with painful cartilage damage in their ankle. MACI uses a patient's own cartilage cells, grown on a special membrane, and compares it to a standard procedure called Bone Marrow Stimulation. The goal is to determine if MACI can more effectively relieve pain and improve ankle function. Suitable candidates experience ankle pain due to cartilage damage, with at least one affected area larger than a dime, and are willing to avoid certain pain medications after treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires you to stop using Non-steroidal Anti-inflammatory Drugs (NSAIDs) for 12 weeks after the study treatment, but you can use low-dose aspirin for clot prevention. After 12 weeks, you can only use over-the-counter pain relievers like NSAIDs or acetaminophen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MACI, a treatment using a patient's own cells on a special collagen layer, is generally safe. Safety data from past studies indicate that most patients did not experience serious side effects. Specifically, a study with many participants found the treatment safe, with no unexpected problems reported.

The FDA has already approved MACI for treating knee cartilage issues, indicating well-documented safety. Although this study focuses on ankle issues, the existing approval suggests overall safety. However, individual experiences can differ, so discussing potential risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for chondral defects, which often involve surgical procedures like microfracture or autologous chondrocyte implantation, MACI (Matrix-induced Autologous Chondrocyte Implantation) offers a unique approach. MACI is distinctive because it uses autologous cultured chondrocytes placed on a porcine collagen membrane, which can potentially improve the integration and durability of the cartilage repair. Researchers are excited about MACI because this method could enhance the healing process by providing a more natural cartilage structure and function, potentially leading to better long-term outcomes for patients.

What evidence suggests that MACI might be an effective treatment for chondral defects?

In a previous study, 74% of patients with successful MACI grafts rated their knees as "good" or "excellent," indicating significant improvement after treatment. Another study with 1,000 patients showed that MACI often succeeds in fixing single cartilage problems. These studies indicate that MACI can help repair cartilage, which is important for smooth joint movement. While these results are promising for knees, the current trial will compare MACI with Bone Marrow Stimulation for treating chondral defects in the talus, a bone in the ankle. ^{1 2 6 7 8}

Who Is on the Research Team?

Jonathon Hopper BSc (Hons), MB ChB, FRCSEd, DIMC RCSEd., MBA, BSc (Hons), MB

Principal Investigator

Vericel Corporation

Are You a Good Fit for This Trial?

This trial is for people aged 17 to 65 with painful and dysfunctional chondral or osteochondral defects of the ankle. Participants must have a specific grade of lesion on the talus, at least one lesion larger than 1.2 cm², and scores indicating significant pain and functional impairment.

Inclusion Criteria

I am between 17 and 65 years old.

I have joint pain and difficulty with function scoring 50 or less on FAOS.

My ankle cartilage damage is severe (grade 3 or 4) and can be treated with surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

2 visits (in-person)

Treatment

Participants receive either MACI implantation or Bone Marrow Stimulation procedure

5-12 weeks

1 visit (in-person) for MACI implantation

Postoperative Rehabilitation

Participants follow a recommended postoperative rehabilitation program

12 weeks

Regular follow-up visits

Follow-up

Participants are monitored for safety and efficacy at multiple time points

104 weeks

Visits at Weeks 6, 12, 24, 36, 52, 78, and 104

What Are the Treatments Tested in This Trial?

Interventions

• MACI

Trial Overview

The study aims to test if MACI (autologous cultured chondrocytes on porcine collagen membrane) is better than Bone Marrow Stimulation for treating symptomatic articular cartilage injuries in the ankle.

How Is the Trial Designed?

Group I: MACI Experimental Treatment 1 Intervention

autologous cultured chondrocytes on porcine collagen membrane

Group II: Bone Marrow Stimulation Active Control 1 Intervention

Surgical procedure

Who Is Running the Clinical Trial?

Vericel Corporation

Lead Sponsor

Trials

14

Recruited

3,100+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667254523000045

MACI (autologous cultured chondrocytes on porcine ...

Of those with intact MACI grafts, 17 out of 23 (74%) rated their knee as “good” or “excellent” and 16 out of 23 (70%) were satisfied with their surgery.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11982059/

Use of MACI (Autologous Cultured Chondrocytes on ...

Most patients had a single cartilage defect treated, and the mean defect size was 4.4 cm2. The patella was the most treated surface (38.4%), ...

3.

maci.com

maci.com/pdf/MACI-PreliminaryUSData.pdf

1000

Case series; Level of evidence, 4. Data were collected for 1000 consecutive patients treated with MACI (on 1010 knee joints) between July 1, 2017 and November.

4.

researchgate.net

researchgate.net/publication/366995084_MACI_autologous_cultured_chondrocytes_on_porcine_collagen_membrane_in_patients_40_years_and_older_Short-term_clinical_outcomes_and_patient_satisfaction

Short-term clinical outcomes and patient satisfaction

Of those with intact MACI grafts, 17 out of 23 (74%) rated their knee as “good” or “excellent” and 16 out of 23 (70%) were satisfied with their surgery.

5.

nature.com

nature.com/articles/s41598-024-59798-7

Comparative study on clinical outcomes in autologous ...

This study investigates the efficacy of a collagen membrane as a substitute for autologous periosteum in atelocollagen-assisted autologous chondrocyte ...

6.

fda.gov

fda.gov/media/101914/download

Package Insert - MACI

MACI, autologous cultured chondrocytes on porcine collagen membrane, is a cellular sheet that. 481 consists of autologous chondrocytes seeded on a 3 x 5 cm ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06915233

NCT06915233 | A Study of MACI in Patients Aged 17 to 65 ...

The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow ...

8.

aetna.com

aetna.com/cpb/medical/data/200_299/0247.html

Autologous Chondrocyte Implantation - Medical Clinical ...

Outcomes included change from baseline in knee function, knee pain, quality of life, and overall health. The investigators reported that 126 ...