Regenerative Medicine Forecast for 2022
Fueled by ground-breaking research, the landscape of regenerative medicine is growing exponentially and is expected to reach $101.3 billion by next year in 2022. Expanded research applications and improvements in biotechnology are driving the market forward in a big way.
The aim of regenerative medicine is based on three important medical pillars:
- Tissue Restoration
- Improved Organ Function.
- Reduction of Disability
Each pillar holds the promise of an improved quality of life for many. In fact, experts say that 1 out of every 3 Americans may benefit from regenerative medicine. The foundation for RM (regenerative medicine) is rooted in stem cell technology. Many of the biomedical approaches used in RM incorporate the use of stem cells often referred to as a type of cellular therapy .
Cellular Therapies
Cellular therapies involve the transplantation of human cells to replace or restore damaged tissue and/or cells. Cellular products are designed to improve the immune system's ability to fight disease. The process starts by collecting a specific set of cells from the blood to manufacture a cellular product.
Cellular therapy products are made from living or once-living cell-based organisms. cellular immunotherapies, molecular-based vaccines, and the use of various cell types such as autologous and allogeneic cells for certain therapeutic indications, including hematopoietic stem cells and adult and embryonic stem cells.
Common Regenerative Medicine Treatments
Regenerative medicine treatment options offer many advantages – mainly because many of the procedures are non-invasive. This translates to faster recovery periods and fewer complications associated with surgical procedures.
Stem Cell Treatment is a type of regenerative therapy that encourages the body to heal diseased, dysfunctional or injured tissues using stem cells or stem cell components.
Cartilage Regeneration is an innovative procedure to replace damaged or worn-down cartilage in the knee. The procedure—called autologous chondrocyte implantation (ACI)—takes healthy cartilage cells from the damaged knee, cultures them in a lab for four to six weeks, and then injects the new cells into the damaged joint for regeneration with the surrounding cartilage.
Platelet-Rich Plasma (PRP) uses injections of a concentration of a patient’s own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints. In this way, PRP injections use each individual patient's own healing system to improve musculoskeletal problems.
Prolotherapy, short for proliferation therapy, is a non-invasive treatment that involves injecting a solution into damaged area of the body in order to regenerate and repair tissue. This type of therapy is geared towards chronic pain patients suffering from various degrees of muscle-skeletal degeneration.
Biomaterials Used in Regenerative Medicine Applications
Biomaterials are essential to regenerative medicine applications. With major advancements in bioengineering, they use the biomaterials to help repair damaged tissues and organs. They are also used towards the treatment of chronic diseases to restore normal body function.
| Biomaterial | Cell Type | Hydrogel Type | Application |
| Bone | Osteoblasts | (PEG), polyethylene glycol, polylactic acid) (PEG-PLA) | Drug-delivery/cell-encapsulation, scaffold for bone regeneration |
| Heart | Bone-marrow-cells embryonic-cells, cardiomyocytes | Fibrin, PEG, alginate, hyaluronic acid (HA), superabsorbent polymer (SAP) | Scaffold for heart tissue engineering |
| Cartilage | Chondrocytes | Fibrin, PEG, SAP | Drug-delivery/cell-encapsulation, scaffold for cartilage regeneration |
| Eye | - | HA | Corneal transplantation |
| Skin | Fibroblast | Collagen, fibrin, HA | Abdominal wall, ear, nose and throat reconstruction, grafting |
| Blood vessels | Stem-cells endothelial cells | PEG, alginate, HA | Vascular grafting |
Challenges in Regenerative Medicine
There are two arms of challenges associated with RM. The first arm deals directly with the hurdles with manufacturing and development. The second arm of challenges speak directly to the regulatory landscape. Although the FDA regulates stem-cell treatments, they continue to still be administered without approval or proper guidance. Consequently, there are two schools of thought with how RM is approached with regards to patient safety.
Patient Education and Consent
Because of aggressive marketing, there is an objective to make sure patients are being educated in a way that allows them to make informed decisions.
Regulatory Controls and Enforcement
Simply stated, this boils down to having a set of check and balances within the clinical space of regenerative medicine for ultimate accountability. Governing RM is necessary to prevent adverse patient outcomes and to also align with better with the guidance objectives set forth by the FDA. Avenues to achieve this benchmark are the subject of many symposiums and conferences around the world. They discuss important solution-oriented data points such as:
- Training and continuing education
- Academia-industry partnerships
- More precise labeling and data management
- Research design methods
- Ethical considerations
- Diverse patient recruitment for clinical trials
Clinical Studies and Research
Regenerative medicine is an exciting industry and this stems from the fact that results from early phase clinical studies are beyond promising. The research applications boast impressive outcomes and many opportunities to improve age and disease-related deterioration of the body.
Coupled with cutting-edge genomic tools, we can expect the medical world to evolve in a myriad of ways. There are many RM-based research applications underway for nearly every genre pertaining to chronic diseases and conditions. Below are a few of areas of cell-based therapies and clinical studies highlighting the vast potential towards improving common health issues:
Cartilage Repair: Researchers at the Stanford University School of Medicine have discovered a way to regenerate, in mice and human tissue, the cushion of cartilage found in joints.
Cancer and Women’s Health: The Cellular Therapies Program at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) demonstrates expertise in stem cell transplantation. Cells are processed at an outside commercial facility or at the Connell and O'Reilly Families Cell Manipulation Core Facility, which has long been at the forefront of producing cell-based therapies for cancer and other diseases.
Hemophilia A: Hemophilia A is a genetic disorder that prevents people living with the disease from forming blood clots. BioMarin Pharmaceutical Inc. is evaluating an investigational gene therapy on patients and currently testing for safety and efficacy with positive early results from the first two trial phases.
Partnering with K2 Scientific
The preserving and culturing of the various biomaterials is a precise science. It is commonplace for many biorepositories to house materials in cold-storage units based upon their optimal temperature recommendations. As such, K2 routinely outfits clinical spaces with a broad range of medical refrigerators and freezers to help safeguard tissue samples and specimens.
Most lab-grade models feature temperature sensors, alarms, and optional backup power sources to help organize your laboratory and eliminate fear of contamination and sample loss. Learn more about K2 Scientific and feel free to contact us with any questions.