hi marling

you wrote:
>Janet
>Have you seen anything on Carticel by the Gonzyme Company?
>I say a very small blurb that said FDA had approved it.  It
>is supposed to help a person regrow cartilage (such as in the
>knee, etc).  I am interested to know if your injury must be
>recent to be effected or would it work on older injuries?
>Thanks Janet (in advance --- that's confidence for ya)

here you go, marling!
i read this yesterday and considered posting it but ...
i hope it's helpful to you


your syb-sib

janet

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FDA Approves Carticel For Autologous Cartilage Repair
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ROCKVILLE, MD, Aug 26 (Reuters) - The US Food and Drug Administration (FDA)
on Monday approved the first autologous cell therapy for cartilage repair,
called Carticel.

The product and process for repairing damaged tissue were developed by
Genzyme Tissue Repair.

Carticel was originally marketed as an unregulated product, but the FDA
later decided that Carticel needed to be reviewed under a new policy
regulating manipulated autologous cells.

Use of Carticel involves harvesting of normal cartilage cells for growth
followed by reimplantation.

Carticel was approved for repair of defects caused by acute or repetitive
trauma. It will not be recommended for treatment of cartilage damage
associated with osteoarthritis, or for repair of damage to the patella.

During the implantation procedure, there is some additional surgery
required, including the cutting away and replacement of damaged tissue.

According to the FDA, "... a thorough and extensive rehabilitation program
... is also considered critical to recovery."

The agency also says that, due to a lack of studies comparing Carticel
procedures with non-Carticel procedures, it is not known exactly how much
the process contributes to knee repair.

FDA is requiring Genzyme to conduct further studies to assess Carticel's
role in repair and to determine long-term outcomes.

The firm is conducting a five-year postmarketing study to assess long-term
efficacy of Carticel compared with other procedures currently in use,
according to Genzyme.

The company will also conduct a second study assessing Carticel's impact on
repair.

Approval was based on case reports of 153 patients in Sweden. Seventy
percent of those followed for at least 18 months showed improvement. In 15
of 22 biopsies evaluated, there was some development of hyaline cartilage.

According to Genzyme, the most frequently reported complications linked to
use of Carticel were hypertrophic tissue at the repair site, adhesions,
superficial wound infection, inflammation of membranes within the joint and
postoperative bruising.

Carticel is not recommended for patients allergic to gentamicin or in
patients sensitive to bovine products.


Westport Newsroom 203 319 2700
Copyright 1997 Reuters Limited.
<http://www.reutershealth.com/news/docs/199708/19970826rgb.html>
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