Medicine Regenerative

REGENERATIVE MEDICINE WITH CELLULAR THERAPY

H2A innovation the ideal partner for regenerative medicine width cellular therapy.

H2A INNOVATION has been operating in the biotechnology sector for several years, integrating experiences and Know How through an external network of collaborations with multinational companies leading in the production of Advanced Therapies (ATMP) and in the marketing of innovative Medical Devices for Autologous Cellular Transplants.

Our skills in scientific communication allow us to reach healthcare professionals in the sector to guide them in the world of Regenerative Medicine, an interdisciplinary sector that integrates constantly evolving research and clinics.

We have developed a commercial network of tissue representatives, who are able to support the clinician in operating room and diagnostic activities by illustrating therapeutic protocols and new clinical applications related to scientific literature.

Today we have developed important partnerships, and we are always looking for innovations to offer cutting-edge Regenerative Medicine methods.

Biology Pills

Cellular therapy is part of that new branch of medicine called regenerative medicine, which aims to regenerate and repair damaged and/or diseased organs and tissues.

Recent studies in stem cells have allowed, in the past 20 years, the development of more innovative techniques that utilize these cells to cure or prevent a vast series of systemic and topic diseases

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STEM CELLS: WHAT ARE THEY?

Stem cells have the unique ability to self-renew and differentiate into a vast array of more specialized cells that make up our body. Stem cells are thus responsible, during the growth and development of the organism,for maintaining homeostasis and supporting tissue regeneration.

EMBRIONAL Stem cells
renowned for their remarkable capacity to multiply indefinitely, can give rise to all types of cells (thus earning the moniker pluripotent).

ADULT or SOMATIC Stem cells
(contained in our body) which do not have the full potential of embryonic stem cells since they have already specialized.

In the context of cell therapy, stem cells can act in two different ways: physically colonize the damaged tissue with subsequent differentiation into the specialized cell type to support the structure and functionality of the tissue, or release molecules that trigger molecular and cellular mechanisms that translate into “therapeutic effect” on damaged tissue.

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MESENCHYMAL STEM CELLS

Mesenchymal stem cells (MSCs) are adult stem cells initially obtained and characterized from the bone marrow but also present and obtainable from many other tissues, such as fat, umbilical cord blood or lymphatic tissues like the spleen, thymus, lymph nodes. MSCs are able to differentiate in vitro (i.e. in certain sterile culture conditions in the laboratory) and in vivo (in experimental animals and humans) into tissues that are very different in terms of embryonic origin and function (adipose tissue, bone, cartilaginous, tendon, skeletal and cardiac muscle, neurons, liver or lung cells, etc.).

MSCs therefore have a pluripotentiality reminiscent of that of embryonic stem cells, without however the ethical implications underlying the latter..

MSCs can migrate to sites very different from those of origin and participate in tissue regeneration phenomena, suggesting enormous application potential in the context of various degenerative, traumatic, congenital and neoplastic diseases, in what is defined as Regenerative Medicine.

MSCs can reduce and control the clinical manifestations of graft-versus-host disease (GvHD) after donor bone marrow transplantation. The application potential of MSCs in the field of autoimmune diseases appears truly very promising.

Recently, primitive mesenchymal stem cells have been identified in umbilical cord gelatin. Compared to MSCs from bone marrow and cord blood these cells, called Wharton's Jelly Cells (WJC), have greater proliferative, immunomodulatory and differentiation potential than bone marrow and cord blood MSCs.

Classification of Cellular Therapy Products.

Cellular Therapy Product Definition (ATMP)

PTC means any preparation that is administered to a human being with purposes similar to medicinal products, and that contains live cells or complex parts of them, whether administered alone or together with matrices/envelopes of synthetic or biological origin. This definition also includes cell populations and products that are part of current clinical practices such as blood transfusions or organ transplants.

In order to clarify its limits, the criteria currently applied for the identification of a PTC are summarized to distinguish them from those consolidated medical practices in which cell populations are isolated, separated and administered to human subjects either in an autologous manner (same donor-recipient) or allogeneic (different donor-recipient):

I. Included in PTC are those products containing cells or parts of them obtained after "non-minimal" manipulation. Non-minimal manipulation refers to those procedures that alter the genetic, physiological, or biological characteristics of the tissue/organ treated.

II Blood transfusions and plasma derivatives are excluded from the PTC and are regulated by specific legislation. Transplants of vascularized organs or of whole tissue are excluded, and therefore those procedures which involve the removal of all or part of an organ or tissue from donors or cadavers and their transplantation in a short time into a recipient subject, after minimal ex vivo manipulation. Minimal manipulation means a procedure that does not alter the genetic, physiological, or biological characteristics of the tissue/organ treated.

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