Advanced Medicinal Products

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What are advanced therapy medicinal products?

ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) are medicines for human use that are based on genes, tissues or cells.

According to the European Medicines Agency classification ATMPs can be divided into three main types:

  • gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting ‘recombinant’ genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources;
  • somatic-cell therapy medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases. Stem cell-based therapy is a category of ATMPs;
  • tissue-engineered medicines: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue.

What are stem cells?

  • Stem cells are precursor of all cells and tissues in human’s organism. These cells can divide in self-renewal to produce more of the same type of stem cells and differentiate into other types of cells.
  • During our life, stem cells are divided and replace those cells, which were damaged, such mechanism ensures organism functioning.
  • With age, quantity of stem cells is reduced, their activity become lower, that is why for human organism it is harder to resist illnesses and to recover.

 

Our treating process

All treatments in the Center of Excellence are performed using mesenchymal stromal cells (also named mesenchymal stem cells, MSCs). In our state-of-the-art Biotechnological Laboratory we prepare for you required amount of the umbilical cord (so-called Wharton’s jelly, an element of human umbilical cord) derived MSCs (UC-MSCs) accordingly to the doctor recommendations.

Types of stem cells

Embryonic and Fetal
Stem Cells

Perinatal Stem Cells

Adult Stem Cells

Isolated from the inner cell mass of blastocysts in early embryonic development, so they are controversial.

These cells are obtained during the period immediately before and after birth. Collection of these cell types does not impact the development of the fetus or newborn, so they are non-controversial.

These are non-controversial cells found in living adults. In adult organism, the sources of ASCs are bone marrow, adipose tissue, peripheral blood, hair follicle, dental pulp and many other sites

Pluripotent stem cells, meaning they are versatile and can specialize into all of the cell types in the body.

Multipotent cells are a middle-range type of stem cell, in that they can self-renew and differentiate into a specific range of cell types.

 

This type of cells is young, that have not yet exhausted their potential.

ASCs are presented by multipotent and oligopotent cells.

Oligopotent cells become further restricted in their capacity to differentiate. While these cells can self-renew and differentiate, they can only do into closely related cell types.

In adult organisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues.

Because ESCs are isolated from human embryos, several questions and issues have been raised about the ethics of embryonic stem cell research and application.

Collection of perinatal stem cells is painless and absolutely safe for mother and child.

Painful procedure to collect stem cells from the patient’s, which usually need anesthesia. Furthermore, the quantity of ADCs declines with age.

The major concern with the possible transplantation of ESCs into patients as therapies is their high ability to form tumors.

The risk of developing a rejection reaction is much lower in case of HSCs transplantation compared to the applying embryonic stem cells, and almost absent in case of MSCs transplantation.

The risk of developing a rejection reaction is much lower in case of HSCs transplantation compared to the applying embryonic stem cells, and almost absent in case of MSCs transplantation.

Large grey market without proven efficiency.

Numerous clinical studies are being conducted worldwide.

Numerous clinical studies are being conducted worldwide.

What are mesenchymal stromal cells?

  • MSCs are non-hematopoietic multipotent stem cells, which can be isolated from different types of tissues including bone marrow, adipose tissue, tooth pulp, and placenta, umbilical cord blood and umbilical cord tissue.
  • Possess an extensive proliferative potential and ability to differentiate into various cell types, including osteocytes, adipocytes, chondrocytes, myocytes, cardiomyocytes, and neurons.
  • MSCs are non-hematopoietic multipotent stem cells, which can be isolated from different types of tissues including bone marrow, adipose tissue, tooth pulp, and placenta, umbilical cord blood and umbilical cord tissue.
  • Possess an extensive proliferative potential and ability to differentiate into various cell types, including osteocytes, adipocytes, chondrocytes, myocytes, cardiomyocytes, and neurons.
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Self-renewing (proliferation)

  • ability to limitless cell division within a given stem cell culture. It means that cells that have such a property will never lose their “stem” nature and will always start new cell generations during each, cyclical cell division.

Differentiation – allowing them to transform into other cell structures, often fully functional. Mesenchymal stem cells can differentiate (transform) among other things into osteoblasts, chondrocytes, fat, skeletal muscle, heart muscle and nerve cells.

Immunosuppressive / immunomodulatory

  • consisting in immunological response, activated by the organism in the case of for example placing a foreign body through its grafting (transplantation). Mesenchymal stem cells inhibit or modify immunological cells operation taking part in responding to the transplantation thus preventing the graft rejection.

Anti-aging (antiapoptotic)

  • mesenchymal cells are able to “save” healthy cells from death if they are damaged due to harmful effects of radiation, hypoxia, chemicals or mechanically damaged.

Angiogenic (neovascular)

  • allowing to secrete chemical compounds stimulating creation of new blood vessels. It is important especially in the process of wound healing as well as in reconstruction of damaged tissue.

Antimicrobial (antibacterial, antiprotozoal)

  • allowing to secrete the same or similar compounds to those secreted by cells of the immune system while combatting pathogens present in the body. Mesenchymal stem cells secrete compounds supporting the immune response to bacteria and parasites.

Anti-inflammatory

  • inhibiting inflammation processes by secreting anti-inflammatory factors. Thus mesenchymal stem cells inhibit activity of the immune system cells and slow down the development of inflammatory condition.

Regenerative

  • that allow to move and find a site of damaged and promote activation of the regenerative processes and increasing their efficiency.

What type of cells are used in the centre of excellence?

  • Umbilical cord derived mesenchymal stromal cells (UC-MSCs)

Why?

  • young
  • more capable of division
  • low risk of virus contamination
  • do not cause immune rejection
  • or tumors’ forming
  • capacity for both autologous and allogeneic grafting

The use of MSCs in the clinical arena is a rapidly advancing field, with about 800 ongoing clinical trials (sources from the public clinical trials database http://www.clinicaltrials.gov, “Mesenchymal Stem Cell” queried on Nov. 8th, 2019)