Data updated: May 26, 2026
Maci (autologous cultured chondrocytes on porcine collagen membrane)
Approved 2016-12-12
1
Indication
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2016-12-12
- Routes
- Implantation
- Dosage Forms
- Cell Sheets
Companies
Active Ingredient: autologous cultured chondrocytes on porcine collagen membrane
Website: ↗
Maci Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2016 to 2016
Dec 2016 ORIGINAL
Update · CBER biologic (Purple Book)
What Maci Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2016)
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06915233 MASCOT | 55-2410-01 | Ph 3 | recruiting | A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle |
| NCT03588975 PEAK | 55-1702-1 | Ph 3 | recruiting | A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee |
| NCT00719576 SUMMIT results posted | MACI00206 2006-004817-16 | Ph 3 | completed | Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Maci FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.