12 February 2016

Macchiarini's colleagues are sure that he was slandered

Kuban doctors came to the defense of Professor Paolo Macchiarini

Kuban 24 

On February 9, Kuban doctors issued a statement regarding accusations that appeared in the media against Professor Paolo Macchiarini, who performed bioengineered trachea transplants in Krasnodar.

The statement was made by the staff of the Kuban State Medical University and the Research Institute – Regional Clinical Hospital No. 1.

"Compliance with ethical principles and the level of professionalism during bioengineered trachea transplants in Krasnodar has been questioned. The basis for such statements by our Swedish colleagues was the documentary "Experiments", which was broadcast on Swedish television at the end of January. We declare that the materials set out in the film concerning operations and research work in Krasnodar are tendentious and distort reality," the statement reads.

According to doctors, transplants of bioengineered trachea, created on the basis of an artificial frame seeded with the patient's own cells, were part of a research, clinical and educational project that was carried out on the basis of the Kuban State Medical University and Krasnodar Regional Clinical Hospital No. 1 under a grant from the Government of the Russian Federation.

"Responding to the accusations that there were not sufficient grounds for the transplantation of patient Yulia T., we would like to note that the candidates for transplantation at the Krasnodar Regional Clinical Hospital were selected after discussion at an international video consultation, which was attended in addition to KKB No. 1 and Professor Paolo Macchiarini, specialists of the RNC im. Academician B.V. Petrovsky (Moscow), the Karolinska Institute and the Karolinska Clinic (Sweden), the Carreggi Clinic of the University of Florence (Italy) and the MD Anderson Clinic of the University of Texas (USA)," the statement reads.

The consultation confirmed that the patients have extensive tracheal injuries, and in recent years they have undergone several surgical interventions that have not yielded significant results. Tracheal transplantation, according to the conclusion of the council, was the only possible solution.

Kuban doctors also noted that the transplantation protocol was approved in accordance with the requirements of the Russian Federation, the ethical Commission of the Kuban State Medical University and the KKB No. All patients met the criteria for inclusion in the clinical trial, were aware of the details of the proposed treatment method and possible complications. All this is confirmed by documentation and videos. Surgeons from different countries were present during the operations, who gave a high assessment of the level of surgical technique.

"We are much more upset than the representatives of the press and the Karolinska Institute that we have not been able to extend the life of our patients for a longer period, despite all our efforts. However, the evaluation of the results of a clinical trial should be given by the professional community, and any unambiguous statements made on the basis of statements by the mass media to the general public, without sufficient grounds and in a categorical form without the availability of reliable information are unacceptable," the statement says.

Kuban State Medical University and Regional Clinical Hospital No. 1 clarified that, if necessary, they are ready to present all information about transplanted patients, which is presented in the form of documents, videos and photographs.

"I would like to note that no news company has ever requested or had a complete list of documents and certificates of operations carried out, so the conclusions and accusations are based on data from the foreign press and materials reflected in the video of the Swedish company SVT (part of the video material is taken out of context, the other is not fully presented and cannot correctly explain what is happening) they cannot be objectively evaluated," the statement published on the website of the GBUZ Research Institute – Regional Clinical Hospital No. 1 notes.

The world's first trachea-larynx transplant operation was performed in the Kuban in 2012. The organs were grown from the cells of two patients. The author of the project was Paolo Macchiarini, Professor of regenerative Medicine at the Karolinska Institute.

Portal "Eternal youth" http://vechnayamolodost.ru 12.02.2015

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