Gamida Cell

History

2016: The second phase of researches of use of stem cells of umbilical blood with NiCord

In August, 2016 the Gamida Cell company published results 2 phases of clinical trials of a new method of use of stem cells of umbilical blood instead of classical transplantation of marrow. According to specialists, use of this technology in practical health care can lead to reduction of death rate after transplantation.

New approach which consists in expansion of umbilical blood by ex Vivo method (in the artificial environment) and the subsequent its transplantation using the medicine NiCord developed in the company is developed for the patients needing transplantation of the haematopoietic stem cells (HSC). Tested show a fast prizhivleniye of a transplant, and results are comparable to "normal" transplantation.

Umbilical blood has several advantages in comparison with marrow and peripheral blood after stimulation, including:

• criteria of fabric compatibility less tough;
• it is available in donor and personal banks.

Umbilical blood shows lower frequency of emergence of reaction "a transplant against the owner" (RTPH). Nevertheless, rather small amounts of umbilical blood and the cages received from it lead to a delay of a prizhivleniye of neutrophils and platelets. The medicine NiCord gives the chance to perform transplantation of cells of umbilical blood to bigger number of patients. The results of researches provided in June, 2016 at a meeting of the American society of clinical oncology (ASCO) show considerable improvements on key indicators, including on time of a prizhivleniye of neutrophils and platelets.

The director of bank of umbilical blood Gemabank Alexander Prikhodko comments:

"So far the prevalence of use of transplantation of umbilical blood was limited by its small amount. For this reason the majority of transplantations of umbilical blood is performed in pediatric practice when rather necessary dose of cages per unit mass the patient's bodies. For adults the problem of a small kletochnost of transplants of umbilical blood is solved performing transplantation at once by 2 samples of umbilical blood. Expansion (reproduction) of cells of umbilical blood can solve this problem. Besides, using new technology and umbilical blood blood formation during transplantation is recovered twice quicker, for 10 day, instead of 21. It significantly reduces risks of performing transplantation for patients. After passing 3 phases of clinical trials can be expected significant increase in demand of umbilical blood around the world".

16 patients with oncological diseases of blood aged from 12 up to 65 years participated in the 2nd phase of a research. To patients carried out miyeloablativny therapy with the subsequent transplantation of umbilical blood using the medicine NiCord. The assessment of results was carried out a year later. Results of researches were compared with data of 125 patients which had similar diseases, however as treatment it carried out transplantation of umbilical blood without the medicine NiCord (data are provided by the International research center of transplantation of marrow and blood (CIBMTR)).

Results of the second phase of the researches NiCord showed:

• 101-fold increase in number of haematopoietic stem cells (CD34+) in comparison with the unprocessed umbilical blood;
• At the patients receiving NiCord neutrophils got accustomed quicker: on average for the 10th day after transaction in comparison with a check group (the 21st day);
• For the 16th day after transplantation at 75% of the patients receiving NiCord neutrophils, in comparison only from 18% at a check group got accustomed;
• The average time of a prizhivleniye of platelets, at patients of the receiving NiCord, took place for the 32nd day; indicators of a check group – the 46th day;
• For the 42nd day after transplantation at 56% of the patients receiving NiCord platelets, in comparison with a check group with an indicator in 27% got accustomed;
• Indicators of death rate were 19% in comparison with 39% in a check group.

It should be noted that new results of researches will be approved with data, provided earlier in 2016, at the 42nd annual meeting of the European association on transplantation of blood and marrow. Then patients after transplantation with NiCord showed the low frequency of bacterial infections and also shorter stay in a hospital after transaction.

These data laid the foundation for a final phase of clinical trials which should confirm the received results, but already on big group of patients. The third phase of researches will begin in 2016, report in Gamida Cell.