Tissue Regenerative Medicine

Regenerative Medical Devices

Regenerative medicine is rapidly growing with bio-engineered medical devices with or without cells and other factors for tissues and cell therapies to aid the body towards repair, remodeling, and regeneration of damaged or diseased cells, tissues and organs.

Regenerative Medical Device Growth Expectations:

The industry of Regenerative Medicine is projected for a phenomenal growth in the coming years, as the nanotechnology of biological devices enhance the field dramatically.

Facets of Regenerative Medicine

• Tissue Engineering: Tissue Repair/Replacement and Lab Grown Organs
• Cellular therapies
• Stem cells
• Natural and Synthetic Scaffolds
• 3-D Printing and Chip Technologies

Role of Medical Devices in Regenerative Medicine

So far, medical devices have not got the opportunity to play a big role in this industry. The reason being there is no proper guidance of characterizing the biological matrix materials. For example, the bio-compatible materials are now well identified due to somewhat poor knowledge based on the biochemistry and nanotechnology of such biomaterials.

Significance of scaffold matrices in Regenerative Medicine

Tissue Engineering (TE) is an interdisciplinary field that applies the principles of engineering and the life sciences towards the development of biological substitutes that restore, maintain, or improve tissue function.

Scaffold

• Provides structural support and shape to construct
• Provides place for cell attachment and growth
• Usually biodegradable and biocompatible

Unfortunately many of the presently available scaffolds are not considering the true biocompatibility and potential immunogenicity resulting out of contaminated preparations. Contamination referred here mainly is that of unwanted biomolecules (like Elastin, Proteoglycans and collagen types other than type-I) present in the scaffold. Such contaminations would eventually supersede the purpose of normal cell-signaling required for bioactivity.

Requirement of Tissue Engineering Product for Tissue Replacement:

Every year, at least a million tissue replacements are being carried out in hospitals across the world. These include soft and hard tissue replacements. Given below is the estimated total number of tissue replacement procedures done per year.

• Skin – 3 million procedures per year
• Blood Vessel – 1 million procedures per year
• Kidney – 600 thousand procedures per year
• Liver – 200 thousand procedures per year
• Nerve – 200 thousand procedures per year
• Muscles tissue
• Heart tissue
• Tendons and ligaments
• Bone – 1 million procedures per year
• Cartilage – 1 million procedures per year

Recognition of Regenerative Medicine by FDA Regenerative Advanced Therapy (RAT):

Recently, FDA put forth the first interpretation of Regenerative Advanced Therapy (RAT) designating a program that was established by the 21^st Century Cures Act’s section 3033. Important takeaways from the FDA’s guidance (Ref 1) on RAT are as follows

1. The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations
2. The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
3. Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

Good Manufacturing Practices (GMP):

Traditional medical devices and therapies are manufactured under GMP conditions. This is to ensure that the products meet the market’s quality standards. As the regenerative medicine takes a major step into main stream medicine, it is necessary to manufacture the biological materials under similar and improved GMP conditions adopted for manufacturing conventional medicinal products.

Disparagers of GMP blame the extremely high costs associated with establishing and maintaining a GMP system. The very design of a GMP system is not made to increase the cost or time of manufacturing, but rather to make sure that the defined quality control procedures are implemented in every single step.

Bio-engineered tissues and cell therapies lie at the core of regenerative medicine. Implementing GMP is the best advised method to standardize these products as opposed to the standardization of a conventional drug or medicine.