ABOUT THE COMPANY
- About the Company
- Medical Products
- Intellectual Property
- History of the Technology
To provide physicians and patients with an affordable and safe cell product obtained from the patient’s own adipose tissue for the treatment of various diseases.
Project compliance with the strategy for scientific and technological development of the Russian Federation (The Decree of the President of the Russian Federation No.642 of December 1, 2016).
Regenerative medicine is an area of modern medical science developing at the intersection of biology and medicine. Cell technologies are one of the most widely used tools of regenerative medicine. The Decree of the President of the Russian Federation of July 7, 2011, No, 899 included cell technologies into the List of Critical Technologies of the Russian Federation. Personalized medicine, in terms of development and implementation of novel diagnostic, prevention and treatment methods, is listed as a priority direction for the development of medicine in the RF in the “Healthcare Development” Program introduced by the Resolution of the Government of the Russian Federation of April 15, 2014, No. 294. These trends and priorities make personalizing regenerative medicine technologies a relevant task of modern high-tech healthcare.
Relevance of the project
The world and Russian science has accumulated great amount of knowledge about the use of various cell types for treatment of many diseases and pathologies. Globally, over 1,500 clinical studies evaluating efficacy and safety of the cell products use in clinical practice are conducted.
Multipotent mesenchymal stromal cells (MSCs) are the most common cell type used as the active substance of the cell product. MSCs can be obtained almost from any tissue of a human body by cultivation in special conditions. In human tissue, the MSC function is to regulate regeneration by producing biologically active substances – cytokines and growth factors. On July 23, 2016, the RF adopted the Federal Law No. 180-FZ “On Biomedical Cell Products” that sets the procedure for launching new products consisting of various cell types obtained via cell culture. This law came into force on January 1, 2017, and plays a crucial role in the development of the industry; subordinate laws specifying the procedure are pending. The so-called minimally manipulated products obtained without culturing outside of the body are an alternative to cultured cells. The adipose tissue is one of the most available and widely used sources of individual (personalized) minimally manipulated cell products. For over 70 years, the adipose tissue has been used in plastic surgery to correct soft tissue defects of various etiologies, and since 2001 – the moment when P. Zuk under supervision of a famed plastic surgeon M. Hedrick first described the presence of MSCs in the adipose tissue – adipose tissue has been extensively used as a source of cell products. However, it was K. Yoshumura, a Japanese plastic surgeon, and scientist, who was the first to describe the basic principles of use of minimally manipulated adipose tissue products in his 2008 paper where he suggested a new concept of using all nucleated cells of the adipose tissue to enrich adipose tissue transplants in lipofilling. Since the adipose tissue consists of a well-developed vasculature and connective-tissue stroma, nucleated cells also contain cells other than MSCs:
- smooth muscle cells
- tissue macrophages
- white blood cells.
The adipose tissue nucleated cells are called the stromal vascular fraction (SVF).
When SVF is introduced into the fat graft, several mechanisms are activated
- modulation of inflammatory and immune responses
- attraction of circulating multipotent cells
- apoptosis inhibition,
which lead to recovery of trophism in transplanted lipograft and any other ischaemic tissues.
The use of SVF in practical medicine is not limited to plastic surgery. Currently extensive research is performed in the area of regeneration of
- nerve tissue
using the stromal vascular fraction obtained from adipose tissue cells which is one of the most used regenerative medicine tools. Extensive studies concerning the use of the adipose tissue SVF in the treatment are performed
- acute graft-versus-host reaction
- chronic autoimmune thrombocytopenic purpura
- rheumatoid arthritis
- Crohn’s disease and other diseases.
Medical devices are developed and already available, that help to obtain a standardized cell product (SVF) in closed disposable systems directly in the operating room. There are two imported devices available in the RF. However, each of them has a number of significant disadvantages like the high cost of device supplies and the devices themselves, along with the lack of Marketing Authorizations for specific parts of the supplies and the enzyme.
Goal of the project
To develop and launch an available Russian device for obtaining the stromal vascular fraction in a closed disposable system “at the point of care”.
- “Device for obtaining cell fractions from human and animal tissue and its use”, application No. 2015147257 of November 3, 2015 – patent was granted
- “Device for obtaining cell fractions from human and animal tissue and its use”, Application PCT No. W1B-1511345
- “Device for fractionating adipose tissue and obtaining stromal vascular fraction from it for the use in regenerative medicine”, Application No. 2017106932
- 2012 – the concept was developed at the University of Chicago.
- February, 2013, – JoinTechCell LLC was founded.
- December, 2013 – a licensing agreement was signed with the rightholder of the IP on the project that gives the exclusive rights on the territory of the Euro-Asian Respiratory Society (EARS), Ukraine, Mongolia, Georgia, and Uzbekistan to the Russian project company “JoinTechCell” LLC.
- October, 2014 – JoinTechCell LLC became a Skolkovo project participant for the project “Development and Implementation of a Closed System of Express-Obtaining and Processing the Fraction of Stem and Regenerative Adipose Tissue Cells for the Use in Medical Practice”.
- 2013–2014 – system’s prototype is created; experiments are conducted in the RF, Israel and the United States.
- August, 2014 – JoinTechCell LLC submitted an application for funding, passed an expert evaluation and received a minigrant from the Skolkovo Foundation to realize the project “Development and Implementation of a Closed System of Express-Obtaining and Processing the Fraction of Stem and Regenerative Adipose Tissue Cells for the Use in Medical Practice”.
- 2014–2015 – joint preliminary trials of the beta 1 version were conducted at the N.F. Gamaleya Science and Research Institute and Ovchinnikov Bioorganic Chemistry Institute, Prototyping was carried out and the miniSTEM ™ Separator Kit design was optimized.
- 2014–2015 – CTs were started in the Dominican Republic and Israel, and preparations for them were made in Europe.
- In 2014–2015, the company did a lot of R&D to develop miniSTEM Comby and miniSTEM Separator prototypes.
- 2015–2016 – 510K was granted by the FDA.
- 2015 – submitting an application to register the invention “Device for obtaining cell fractions from human and animal tissue and its use” (November 3, 2015, No. 2015147257).
- In 2016, the company received a status of the Kaluga Pharmaceutical Cluster member.
- In 2016, the company entered into a partnership with the KOL of the project, Ilya Igorevich Eremin (https://clinicaltrials.gov/ct2/results?term=eremin&Search=Search), and the Center for Biomedical Technologies of the CCH with the Polyclinics!
- Since the end of 2016, the company has started the pilot production of miniSTEM Comby and miniSTEM Separator. Manufacturing partners of the project: LISTON, AB Universal, ZAO Polimer, Techostnastka, SteriPACK.
- In 2016, the Company and the project’s KOLs presented reports at ISPRRES and IFATs.
- 2017 – we submitted an application to register the utility model “Device for fractionating adipose tissue and obtaining stromal vascular fraction from it for the use in regenerative medicine” (March 2, 2017, No. 2017106932).
(2) А. Веремеев, Н. Кац, Р. Болгарин, М. Петкова, И. Корниенко, А. Мелерзанов, Н. Мантурова, В. Нестеренко ПОЛУАВТОМАТИЧЕСКАЯ СИСТЕМА ДЛЯ ВЫДЕЛЕНИЯ СТРОМАЛЬНО-ВАСКУЛЯРНОЙ ФРАКЦИИ ЖИРОВОЙ ТКАНИ // Журнал ВРАЧ, январь 2017, с. 68-72
Articles in peer-reviewed scientific journals:
- A.V. Veremeev, N.G. Kats, R.N. Bolgarin, M.A. Petkova, I.A. Kornienko, A.V. Melerzanov, V.G. Nesterenko “miniSTEM – a system for extraction of adipose tissue stromal vascular fraction” / Vrach, Moscow, 2016;
- A.V. Veremeev, N.G. Kats, R.N. Bolgarin, M.A. Petkova, V.G. Nesterenko “The adipose tissue stromal vascular fraction as an alternative source of cell material for regenerative medicine” / Geny i Kletki, Moscow, 2016.
Results were presented at the 2nd national congress on the regenerative medicine (Moscow 2016):
A.V. Veremeev, M.A. Petkova, E.M. Gretsov, R.N. Bolgarin, N.G. Kats “Characteristics of the adipose tissue stromal vascular fraction obtained using the miniSTEM system / The 2nd National Congress on the Regenerative Medicine, Moscow, 2016.