Identification
- Summary
Autologous cultured chondrocytes is a cell therapy used to treat damage to cartilage in the knees.
- Brand Names
- Carticel
- Generic Name
- Autologous cultured chondrocytes
- DrugBank Accession Number
- DB10997
- Background
Autologous cultured chrondrocytes are used as autologous cell therapy to repair articular cartilage injuries in the knee (femoral condyle) due to acute or repetitive trauma. It serves as an alternative repair treatment for patients with inadequate response to pre-existing surgical methods. The surgical implantation shows a tolerable safety profile and efficacy up to 4 years, but it is not indicated for patients with osteoarthritis. It has been used since 1995 as Carticel and gained biologic license in 1997. The surgical implantation was first performed in Sweden.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Cell transplant therapies
Autologous cell transplant - Synonyms
- Not Available
Pharmacology
- Indication
in Autologous cultured chondrocytes are indicated the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults aged 55 years and less.7
They are not indicated for use in joints other than the knee.7
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Articular cartilage defects of knee •••••••••••• ••••• ••••••• Management of Articular cartilage defects of knee •••••••••••• ••••• •••• ••••••••••• ••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Autologous cultured chrondrocytes reduce pain and considerably improve function in patients with defected cartilage at femoral joints by producing hyaline-like cartilage repair tissue.
- Mechanism of action
Chrondrocytes are collected from the patient's femoral articular cartilage and isolated cells are expanded through cell culture in vitro. Multiplied chrondrocytes are implanted into articular cartilage defects beneath an autologous periosteal flap. Cells produce hyaline-like cartilage that mainly consists of type II collagen. Type II collagen maintain the macromolecular framework in the extracellular matrix that gives integrity to surrounding hyaline cartilage. The therapy repairs damaged cartilage and restores functional and mechanical ability to withstand compressional, tensile, and shear forces.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Unwanted effects from therapy include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion and graft delamination in less than 5% of total patients who underwent treatment.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Carticel Implant 1.2e+007 1/1 Intra-articular Genzyme Corporation 1997-08-22 2014-06-03 US 
Carticel Implant 1.2e+007 1/1 Intra-articular Vericel Corporation 1905-06-19 Not applicable US Chondrocelect 10000 cells/?l Ti Genix N.V. 2020-12-16 2017-01-12 EU 
Spherox 40 spheroids/cm² Co.Don Gmbh 2020-12-22 Not applicable EU Spherox 40 spheroids/cm² Co.Don Gmbh 2020-12-22 Not applicable EU - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Maci Autologous cultured chondrocytes (15000000 1/1) + Pork collagen (15 cm2/1) Implant Intra-articular Vericel Corporation 2017-06-09 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- D5P3K3V822
- CAS number
- Not Available
References
- General References
- Melrose J: The knee joint loose body as a source of viable autologous human chondrocytes. Eur J Histochem. 2016 Jun 10;60(2):2645. doi: 10.4081/ejh.2016.2645. [Article]
- Nazempour A, Van Wie BJ: Chondrocytes, Mesenchymal Stem Cells, and Their Combination in Articular Cartilage Regenerative Medicine. Ann Biomed Eng. 2016 May;44(5):1325-54. doi: 10.1007/s10439-016-1575-9. Epub 2016 Mar 17. [Article]
- Akkiraju H, Nohe A: Role of Chondrocytes in Cartilage Formation, Progression of Osteoarthritis and Cartilage Regeneration. J Dev Biol. 2015 Dec;3(4):177-192. Epub 2015 Dec 18. [Article]
- Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L: Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. [Article]
- Zhang W, Ouyang H, Dass CR, Xu J: Current research on pharmacologic and regenerative therapies for osteoarthritis. Bone Res. 2016 Mar 1;4:15040. doi: 10.1038/boneres.2015.40. eCollection 2016. [Article]
- Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen O: Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial. J Bone Joint Surg Am. 2004 Mar;86-A(3):455-64. [Article]
- FDA Approved Drug Products: MACI (autologous cultured chondrocytes on porcine collagen membrane) Cellular sheet for autologous implantation [Link]
- External Links
- PubChem Substance
- 347911074
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Autologous_chondrocyte_implantation
- FDA label
- Download (142 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Cartilage, Articular 1 3 Completed Treatment Articular Cartilage Defects 1 3 Completed Treatment Articular Cartilage Lesion of the Femoral Condyle 1 Not Available Completed Not Available Articular Cartilage Defects 1 Not Available Completed Not Available Cartilage Diseases / Cartilage, Articular 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Implant Intra-articular 1.2e+007 1/1 Implant Intra-articular - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at December 01, 2015 20:05 / Updated at March 17, 2022 22:25