November 22, 2021
Dr. Lana du Plessis
November 22, 2021
Dr. Lana du Plessis
Regenerative therapy is the healing or replacement of tissues or organs that have been damaged by disease, trauma, or congenital issues, as opposed to the age-old clinical approach that relies primarily on the treatment of symptoms. Four disciplines are used in regenerative therapy, i.e., tissue engineering, cellular therapies, medical devices and artificial organs.
The field of regenerative therapy is quite new and various combinations of the aforementioned methods can be used to treat patients. The field involves a combination of disciplines, for instance: biology, chemistry, computer science, engineering, genetics, medicine, robotics, and other fields to find solutions. The ultimate goal of Regenerative Medicine is to find a way to cure previously untreatable injuries and diseases.
Tissue engineering is the application of biologically compatible scaffolds that are implanted in the body at the site where new tissue is to be formed. The scaffold might be in the geometric shape of the tissue that needs to be formed, the scaffold might attract cells or cells will be implanted and the outcome is new tissue in the shape desired.
Stem cells are important for the body to repair itself and many millions of adult stem cells are found in every human. These cellular therapies involve the use of adult stem cells that are injected at the site of diseased or damaged tissue, where the rebuilding of the tissue is possible under the right stimuli. These adult cells can be collected from blood, fat, bone marrow, dental pulp, skeletal muscle, and other sources. Cord blood is one of the most unique and potent sources of stem cells currently in use.
In cases where an organ fails, the main clinical approach is to transplant a substitute organ from a donor. One of the major challenges are the availability of donor organs and the requirement that the donor takes immunosuppression drugs—which have significant side effects and risks. A novel strategy that has emerged is the 3-D printing of organs. In this way, the stem cells that build the new organ are manipulated to form the tissue of the specific organ and these cells will populate a 3-D scaffold of the organ. These stem cells can be engineered from the same patient’s cells and thereby any organ rejection will be eliminated.
Studies have shown promising results in treating burns, heart disease, trauma and other diseases.
To quote the Biopharma Reporter:
“We are on track for a watershed year for approvals of new regenerative medicine and advanced therapies globally. Decisions are expected on 18 regenerative medicine products across 6 geographies, with 10 of these on products that have never been previously approved in any geography – meaning new product approvals could exceed the record of nine set in 2016.”
There are currently 2,600 clinical trials ongoing worldwide in this sector, of these 1,320 are industry-sponsored and an additional 1,328 non-industry sponsored. There are 243 trials in Phase 3, including 1158 industry-sponsored trials and 85 trials sponsored by academics, the government and other institutions. The late-stage products are being tested for instance in diabetic neuropathy, heart failure, rare genetic diseases, and neuromuscular diseases.
The biggest buzzword in the industry is “off-the-shelf” therapies, which are easily accessible. Therefore, as the field continues to grow, developers are seeking to work more closely with regulators to set improved standards. All these developments in the field of regenerative medicine across a broad scope of medical disciplines will ultimately aid in new solutions to expand and sustain optimal health and quality of life.