Friday, 25 January 2013

Rush University Medical Center announces human clinical trial for Cartistem

The Rush University Medical Center (RUMC) announced yestesome very good news yesterday, for people with cartilage defects. Specifically, it will soon begin a human clinical trial involving Cartistem, a stem cell product for cartilage regeneration. The phase I/IIa study will last for two years and a total of 12 patients are expected to enrol.

Cartistem is a stem cell product containing mesenchymal stem cells (MSCs), extracted from umbilical cord blood. The MSCs are mixed with hyaluronan, a polymer which according to the announcement, promotes wound  healing and cartilage regeneration. The product is administered via a minimally invasive operation (arthroscopy) and is placed in the damaged area after a microfracture has been performed. Microfracture is one of the oldest techniques for cartilage regeneration. However, the cartilage generated via microfracture alone is fibrocartilage and not true hyaline cartilage. Fibrocartilage is of inferior quality and many times the results of microfracture are less than optimal. Cartistem has shown in previous studies great promise in generating cartilage that is closer to the original hyaline cartilage and thus better short and long term results. 

A cartilage lesion after microfracture

Please be aware that Cartistem is a product for treating localised cartilage defects only, resulting from trauma, tear and wear, osteochondritis dissecans etc. It is not aimed for treating widespread artthritis.

Goal of the clinical trial is to test the safety and efficiency of the Cartistem product in patients with localised cartilage defects. As mentioned before, 12 patients will be enrolled. At first, 6 patients with cartilage defects measuring 2 to 5 centimetres will be treated, and later 6 more with bigger lesions will be enrolled.
Some requirements for participating in the study are the following:
  • Patients must be at least 18 years old
  • Patients must have a BMI (body mass index) that is less than 35
  • Patients must be willing to undergo several tests for a period of 2 years
If you are interested in participating, please call the Rush University Medical Center at (312) 563-2214.

Cartistem is already approved ,since January 2012, by the Korean Food and Drug Administration (KFDA)
for the treatment of small cartilage defects

Informational video about Cartistem

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