Origins of Regenerative Medicine: The Untapped Potential of Personalized Solutions

Disclaimer: The following text includes information pertaining to cell-based therapies, stem cells, and gene therapies. Please note that this information in no way reflects any current product offerings or product claims provided by StimLabs LLC. The inclusion of this information within the text below is only for educational purposes and does not reflect the products, goals, or opinions of StimLabs, LLC as a company.

In the words of Winston Churchill, “those that fail to learn from history are doomed to repeat it.” Origin stories are powerful because they provide us with a roadmap that propels us forward toward success and improvement and safeguards us against making mistakes or ineffectual choices. In this origin story of regenerative medicine, we’ve delved into the early beginnings of the field and examined centuries of the exploration, experimentation, successes, and failures that brought us to present-day regenerative medicine. For our final post in this blog series, we will turn our eyes to the current state of regenerative medicine, the future of this promising field, and the role that we as a company would like to play in that future.

For the first time in recorded human history, humankind may be winning the war against ailments that would have previously carried a death sentence. Cancer, blood disorders, genetic defects, infections, and rare diseases are slowly but surely meeting their matches in today’s medical breakthrough therapies. Many of these therapies belong to the field of regenerative medicine.

Teamwork makes the dream work

 At StimLabs we see the incredible value that teamwork can provide in finding solutions and driving innovation. The regenerative medicine industry is also harnessing the knowledge and challenges faced across industry and academia to drive forward the reality of regenerative therapies. To that end, the Alliance for Regenerative Medicine (ARM) was founded in 2009 and is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. One important function of ARM is to promote legislative, regulatory, reimbursement, and manufacturing initiatives to advance this sector.

The sector of regenerative medicine is largely divided into 3 main groups – cell therapies and tissue-engineering products, which we briefly touched on in our previous post, and gene therapies, the proverbial new kid on the block.¹  Until recently, Industry has been the main source of funding for regenerative medicine clinical research; however, the funding landscape has begun to evolve with non-industry entities (e.g., government and academic research institutions) surfacing as benefactors of clinical trials in the regenerative medicine space.¹ From 2020 to the first half of 2021, there was an increase of 100 regenerative medicine and advanced therapies trials with 1,320 being industry-sponsored and another 1,328 trials in phases 1, 2, or 3 sponsored by non-industry entities ongoing worldwide.¹

Percentages of sponsored trials by phase for industry (left) and academic/government/other entities (right) Jan-Jun 2021¹

The increase in support from non-industry entities along with the continued contribution of industry players represents a powerful force to continue driving the field of regenerative medicine forward.

Cell and gene therapies are taking the world by storm

Cell therapies, cell-based immunotherapies, and gene therapies are the trending therapies of today’s regenerative medicine landscape based on current clinical numbers.¹ As we will later see, these fields are highly promising and will likely continue to increase in scope.

Cell Therapies-

If you’ll recall from our last post, cell therapies are designed to treat damaged or diseased tissues by transplanting new and healthy cells into the tissue.² Cell therapies represent the largest component of clinical trial research in the regenerative medicine space with 1,271 trials currently underway.

Cell Therapy Clinical Trials Underway Jan-Jun 2021¹

 One cell therapy that is growing in popularity is induced pluripotent stem cells (iPSCs).¹ iPSCs are adult stem cells that can be reprogrammed using chemical signaling to become pluripotent, meaning they can differentiate into cell types of almost every tissue in the body.^2,3 Ongoing evaluations of iPSCs include a number of conditions including retinal degeneration, cutaneous wounds, heart infarctions, and skeletal muscle degeneration.⁴

Cell-based Immunotherapies-

Another type of regenerative medicine therapy that represents a growing percentage of clinical trial research is cell-based immunotherapy. As of the first half of 2021, there were 964 ongoing clinical trials studying cell-based immunotherapies.¹

Cell-based Immunotherapy Clinical Trials Underway Jan-Jun 2021¹

Cell-based immunotherapies are the result of a canny marriage between cell therapy and gene therapy wherein a patient’s cells are collected, genetically modified, and then re-introduced into the patient’s body in order to fight disease.¹ I chose chimeric antigen receptor (CAR) T cell therapies to feature in today’s post because a) they are totally cool, and b) they are crushing it with the number of approvals and positive data readouts over the last year.¹ CAR T cell therapies are currently being developed to treat certain cancer types such as myelomas, leukemias, and lymphomas.^1,5 Pretty amazing stuff when you consider that 100 years ago, scientists didn’t even really know how T cells function or what their role is.

Gene therapies-

The last group of therapies I want to discuss in this section is gene therapies. There are currently more than 300 ongoing clinical trials studying gene therapies worldwide.¹

Gene Therapy Clinical Trials Underway Jan-Jun 2021¹

The intent of gene therapy is to modify or introduce genes into a patient’s body with the goal of durably treating, preventing, or potentially even curing disease. This innovative technique is currently being studied in several types of cancer, viral diseases, and inherited disorders and may represent the industry’s first attempts at not only curing diseases but preventing them altogether.¹ One such example of an up-and-coming gene therapy is a technique known as CRISPR/Cas-9. In a nutshell, CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeat and Cas-9 is a CRISPR-associated enzyme protein. The CRISPR/Cas-9 system is a bacteria’s version of the immune system that protects them from invading viruses. This system relies on the detection and silencing of foreign genetic materials via specialized enzymes. Once the foreign genetic material is silenced, it can’t carry out a proper infection thus – crisis averted. This system is currently being studied in a wide array of disease conditions including sickle-cell anemia, hereditary blindness, and cancer.^6,7

Tissue engineering represents an underutilized resource in the field of regenerative medicine

Despite being one of the oldest disciplines in the regenerative medicine game, tissue engineering currently represents the smallest sector of regenerative medicine with only 37 trials worldwide.¹

Tissue Engineering Products & Biomaterials Clinical Trials Underway Jan-Jun 2021¹

Trials by Sector Underway Jan-Jun 2021¹

To break this statistic down even further, there are 588 industry-sponsored regenerative medicine trials with sites in the US and only 6 of them are for tissue engineering products.¹ This represents a tremendous opportunity for innovation to engineer tissue products that can be used in a variety of conditions including wound care, surgery, dermatology, etc.  

StimLabs’ role in the future of regenerative medicine

To date, StimLabs has developed a suite of next-generation placental tissue products for a variety of applications including wound care, surgery, and dermatology. StimLabs recognizes the untapped potential within the field of regenerative medicine for innovative and personalized solutions, particularly in the tissue and biomaterials space. Our long-term goal is to become a key player in the field with a robust and diverse product development pipeline. This last year has been one of tremendous growth for StimLabs. We grew to a team of over 200 employees, shipped over 28,000 grafts to 40 states across the US, and expanded our patent portfolio across our current commercial lines! To keep up with our growing business, we also established Beyond Birth, a birth tissue donation program. With this new program, StimLabs is able to work more closely with expectant mothers who opt to donate their birth tissues for transplant to patients facing a variety of medical conditions. To ensure this new donation opportunity is fully embraced, StimLabs expanded our tissue processing lab to allow for a 200-250% increase in our production capacity, with triple the number of biosafety cabinets, and more custom freezers, lyophilizers, and refrigerators. While supporting our growing placental-derived portfolio, StimLabs continues to innovate in the regenerative medicine field by exploring new raw materials to develop unique solutions for our patients and providers. In Q1 2022 StimLabs became a member of the Alliance for Regenerative Medicine as part of our strategy to propel the development of our regenerative medicine pipeline. With our growing and evolving product pipeline, we aim to reach even more patients and provide more options for treating a variety of medical conditions at different sites of service.

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1. Alliance for Regenerative Medicine. (2021). Regenerative Medicine in 2021: A Year of Firsts and Records; H1 2021 Report. https://alliancerm.org/sector-report/h1-2021-report. Accessed 2 December 2021. 2. Sampogna, G., Guraya, S. Y., & Forgione, A. (2015). Regenerative medicine: Historical roots and potential strategies in modern medicine. Journal of microscopy and ultrastructure, 3(3), 101–107. https://doi.org/10.1016/j.jmau.2015.05.002. 3. Zakrzewski, W., Dobrzyński, M., Szymonowicz, M., & Rybak, Z. (2019). Stem cells: past, present, and future. Stem cell research & therapy, 10(1), 68. https://doi.org/10.1186/s13287-019-1165-5 4. Jarrige, M., Frank, E., Herardot, E., Martineau, S., Darle, A., Benabides, M., Domingues, S., Chose, O., Habeler, W., Lorant, J., Baldeschi, C., Martinat, C., Monville, C., Morizur, L., & Ben M’Barek, K. (2021). The Future of Regenerative Medicine: Cell Therapy Using Pluripotent Stem Cells and Acellular Therapies Based on Extracellular Vesicles. Cells, 10(2), 240. https://doi.org/10.3390/cells10020240 5. National Cancer Institute (2021). CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells. Accessed 2021, October 21. 6. Ledford H., Callaway E. (2020). Pioneers of CRISPR Gene Editing Win Chemistry Nobel. Nature, 586, 346. 7. Jinek, M., Chylinski, K., Fonfara, I., Hauer, M., Doudna, J. A., & Charpentier, E. (2012). A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity. Science (New York, N.Y.), 337(6096), 816–821. https://doi.org/10.1126/science.1225829