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From Italian research - Platelet Gel for treating diabetic ulcers

Milan, 5 June 2015 – A possible solution for healing ulcers caused by diabetes, one of the most common complications of this disease, could spring from the intuition of Italian researchers. In fact, a clinical trial with 200 diabetic patients enrolled has been started up to verify the effectiveness of Platelet Gel, the initial results of which will be obtained at the end of the year. Experts from all over the world will address this issue at the convention entitled “A life that is born makes life grow. Umbilical cord blood: experience and future”, organised on June 5 and 6 in Milan by the Milano Cord Blood Bank – Transfusion Centre Foundation, Ca’ Granda Ospedale Maggiore Polyclinic of Milan and promoted by the Fondazione Internazionale Menarini with the support of the Lions Club.

“Platelet Gel is obtained from the umbilical cord blood, collected at the end of childbirth. This blood, which is rich in “haematopoietic” stem cells, that is, the cells that generate all the cells making up the blood, has been used for over 30 years with excellent results for transplants in patients with serious blood diseases such as leukaemia lymphomas”, explains Paolo Rebulla, Director of the Milano Cord Blood Bank and chairman of the convention.  “Clinical experience indicates however, that the success of the transplant is closely linked to the number of stem cells present in the cord blood, and as a result it is not a good idea to continue to store donations in the blood banks that contain less than 1,500 million cells, due to the fact that these donations would have little chance of being requested for transplants. Many blood banks, including the Italian ones, have therefore decided to only store donations containing a higher dose of cells”. Consequently, by using these donations not considered suitable for transplants, about five years ago the researchers of the Polyclinic of Milan started to study other possible therapeutic applications and Platelet Gel was created from these studies.

“The high percentage of cord blood discards prompted us to perfect a method of preparing Platelet Gel from cord blood”, continues Rebulla. “The procedure consists of a ‘miniaturisation’ of the method normally used to prepare the platelet concentrates from adult donors that we use for transfusions in patients with leukaemia. The finished product consists of a suspension of approximately ten billion platelets in 10 millilitres of plasma that is kept frozen, and at the time of use, after being thawed, an adequate dose of calcium is added to encourage the formation of a gel. This gel is used to treat bedsores and skin ulcers. The preparation method has been patented to protect the intellectual property of the public structure where it was invented. The Unites States patent office has recognised the innovation of our invention, granting the patent for the preparation method that is held by the Polyclinic”.

Platelet Gel was initially used in children suffering from epidermolysis bullosa, also called the “Syndrome of butterfly children”, a rare and devastating genetic disease that affects 1 child out of 82,000 births in Italy and 1 out of every 17 thousand in the world, for a total of approximately 500 thousand patients.  Epidermolysis bullosa is a genetic disease that makes the skin and mucous membranes extremely fragile and causes pimples, blisters and continual lesions due to the detaching of the epidermis (the superficial layer of the skin) from the derma (the deeper part) as a result of rubbing and even minimal friction, and at times even spontaneously. This causes infections, pain, loss of liquids, imbalances in the haematic parameters, and even the development of skin cancer in the more serious cases.

“We have recently published a clinical trial conducted at the IRCCS Foundation, Ca’ Granda Ospedale Maggiore Polyclinic of Milan, the result of collaboration between the transfusion service and the paediatric unit. This trial demonstrated how treatment of an ulcer with the gel of cord blood gives rise to much faster healing than treatment with classical procedures”, adds  Rebulla.

Following the brilliant results of the experience of the Polyclinic of Milan on epidermolysis bullosa, the cord-blood banks of the Italian network (ITCBN) were asked to participate in a national study coordinated by the National Blood Centre for the purpose of standardizing the production of Cord Blood Platelet Gel (CBPG) unsuitable for use in transplants.  Thirteen blood banks took part in the study activities that lasted one year (November 2013- December 2014) and produced more than a thousand units of gel.

Today the challenge concerns a disease that is far more widespread among the population: diabetes. “The results obtained have strengthened our conviction that it is possible to use Platelet Gel in other clinical applications. In particular, in view of the effectiveness in healing the epidermolysis bullosa skin lesions, we have proposed a clinical protocol for the application of Platelet Gel in diabetic ulcers. The enrolment of patients started in January this year and is still continuing. The goal of the experimentation is to assess whether Platelet Gel is more effective than the traditional medications in healing diabetic ulcers. This would lead to a reduction in treatment costs and an improved quality of life for the patients”.

   
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