UKM Signs Agreement to enable Clinical Trial for KULITKU
THURSDAY, 20 MAY 2010 16:04
BY ABDUL GHANI / SHAHFIZAL
Bangi, 20 May, 2010.– People suffering from massive skin lost due to burns and accidents will soon be able to again have healthy skins patch up their wounds once an innovation in tissue engineering pioneered by Prof Dr Ruszymah Hj Idrus of UKM is clinically tested and approved for use.
An agreement to enable this trial was signed by Prof Dato’ Dr Mohammed Noor bin Embi, Director of the Centre for Innovation and Collaboration, UKM and Mr Raymond Wood, Managing Director of Cell Therapies Pty. Ltd . of Melbourne, Australia in Bangi today.
The agreement is to transfer an internationally recognized quality system to the UKM-MTDC cGMP (current Good Manufacturing Practice) facility enabling clinical trials for medical breakthroughs to be done and to allow medical inventions for medical treatment.
UKM with the collaboration of MTDC (Malaysian Technology Development Corporation), have successfully initiated the construction of a cGMP facility located on the 12th Floor of UKM Medical Centre since early 2010
This will be the first cGMP facility for human cell and tissue processing in Malaysia that will be accredited by National Pharmaceutical Control Bureau (NPCB) under the Ministry of Health. It will also serve as a gateway for other innovative products from TEC (Tissue Engineering Centre) such as cartilage, bones, corneas and other cellular and tissue based therapies such as stem cell therapy to reach the Malaysian patients.
. cGMP is the Current (Code of) Good Manufacturing Practices adopted by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity.
With the agreement clinical trials can now be carried out at UKMMC. The first clinical trial to be carried out in the facility is KULITKU, the tissue engineering innovation carried out by Prof Ruszymah, who is the head of TEC in the Medical Faculty of UKM.
Prof Mohammed said that though patent for KULITKU was granted in 2008, the unavailability of an accredited lab has halted the process of bringing the innovation to the bedside. With the agreement for the setting up of the cGMP facility clinical trials can now be carried out for KULITKU.
Mr Wood said that the cGMC lab is a powerful bridge which will convert research into tangible benefit to the patients. The agreement provides a site license for UKM to use and develop quality systems to TEC’s activities. The objective is to translate UKM research from the laboratory to the clinic.
Currently treatment for massive skin loss is to do a split skin graft (SSG) where a layer of skin is removed from a healthy part of the body (donor site) and grafting it onto the wound. SSG though effective have several disadvantages.
it requires harvesting of a large area of skin from donor site which might increase risk of infection, there may be a limited amount of good skin available for patients with massive skin loss, the process is more painful and may result in scarring and SSG is not advisable for patients with compromised healing abilities such as diabetic individuals.
KULITKU on the other hand requires only a small piece of healthy skin and grows it exponentially. A skin biopsy of just 3 square centimeters can generate 100 square centimeters of skin after separate culturing of keratinocytes and fibroblasts (cells which made up the epidermal and dermal layers in skin). Scarring from this procedure will be minimal and it would be less painful and reduce risk of infection especially for patients with impaired wound healing like diabetics.