Stem cell research and trials of stem cell therapies and treatments represent exciting advancements in medicine, in particular, regenerative medicine. This innovation drives us and, at Celixir, our patient’s needs motivate everything that we do. All of our efforts are focused on bringing life-saving medicines to the market.
With more than 20 tissue-specific regenerative medicines in our pipeline, we want the public to understand what stem cells are, their potential in treating a range of formerly untreatable conditions, and why their use in medicine has been considered controversial in the past.
1. Different Stem Cells Serve Different Purposes
There are four major different types of stem cells:
Embryonic Stem Cells: ES Cells are cells derived from early stage pre-implantation embryos. In order to harvest these stem cells, an embryo has to be fertilized in a laboratory as opposed to inside the female body. ES cells are pluripotent, meaning they can divide into more stem cells and can become other types of cells in the body.
Adult Stem Cells (Tissue-Specific Stem Cells): Adult stem cells (found in both children and in adults) come from developed organs and tissue. They can self-renew indefinitely to replenish dying cells and to regenerate damaged tissue but they cannot differentiate into as many other types of cells as embryonic stem cells can.
Induced Pluripotent Stem Cells (iPSCs): Scientists have recently discovered how to reprogram adult stem cells to act more like pluripotent, embryonic stem cells. They have the potential to produce new cells for any organ or tissue in the body and can be made from someone’s own skin, potentially preventing rejection from the immune system.
Cord Blood Stem Cells: After childbirth, stem cells can be harvested from the umbilical cord and frozen for future use.
2. Stem Cells Could be Used to Treat Everything from Heart Disease to Autism
Because stem cells can differentiate themselves into a range of adult cells, they can potentially treat any disease that causes and is perpetuated by the destruction of cells and tissues.
At Celixir, we’ve focused our efforts on how iMP cells (Integral Membrane Protein) can treat patients with heart disease. Around the world, scientists have found stem cells to be useful in treating Parkinson’s Disease, Diabetes, Leukemia and even menopause. Scientists are also closer than ever to finding a cure for Human Immunodeficiency Virus (HIV) because of extensive stem cell research.
3. Stem Cells Could Regenerate Tissues, Bones and Cartilage
Cell-based bone and cartilage replacement is an evolving therapy that could help amputees and patients struggling with autoimmune diseases that attack and destroy cartilage tissues in the body. Dental stem cells are even being used to grow teeth and reconstruct jawbones.
4.There is Controversy Surrounding Stem Cell Research and Treatment
The controversy surrounding stem cell research and treatments is moral rather than scientific. Namely, opponents believe that harvesting embryonic stem cells and destroying fertilized embryos is wrong and that embryos should be protected with the same rights as humans.
On the other side of the argument, supporters believe that embryos aren’t yet humans. What’s more, donor couples whose eggs and sperm were used to create the embryo give their consent in putting forth their embryo to be used in valuable, potentially life-changing scientific research.
Now, with iPSCs, there’s less of a need for human embryos in research which has alleviated some concern for opponents.
5. Embryonic Stem Cells Were First Identified Less Than 40 Years Ago
Scientists only just discovered how to harvest embryonic stem cells from mice in 1981. Just 17 years later, scientists created a method to do the same with human embryos, effectively growing embryonic cells in laboratories. In 2006, a team of scientists in Japan successfully reprogrammed adult cells to create iPSCs, putting to rest some of the ethical and moral debates surrounding stem cell research. In 2014, the first human trial using stem cell therapy was approved. Today, clinical trials using stem cells are being approved around the world, including Celixir’s own Heartcel in Europe and the US.
6. Stem Cells Have Been Proven to Work
Keep up with the latest stem cell and regenerative medicine news on our blog. We cover everything from how stem cells could regenerate lung tissue to how stem cells could heal patients’ brains post-stroke.
7. Unfortunately, Stem Cell Therapy is Restricted in Some Parts of the World
While stem cell research is widely funded and supported (either federally, locally or privately) in the UK, US, Canada, Spain, Sweden, Belgium and South Korea, research and therapy in Germany, Italy and Austria is restricted.
8. You Can Preserve Your Child’s Stem Cells
Stem cell banks can store stem cells derived from amniotic fluid or umbilical cords for future use. Cord blood has been used to treat over 80 diseases.
9. Regenerative Medicine and Tissue Engineering Are Different
Tissue engineering is an interdisciplinary field which applies the principles of engineering and science to develop biological substitutes that restore, maintain, or improve tissue function. The key word here is develop. Tissue engineering has the capacity to build biologic materials.
Regenerative medicine doesn’t require the production or growth of biological substitutes. Rather, regenerative medicine is any therapy aimed at restoring function.
10. It Takes Time for Treatments to be Approved
Recently, regulatory bodies like the FDA have released new guidelines to ensure the delivery of safe and effective regenerative medicine advanced therapies (RMATs). As it stands, stem cell derived products that are minimally altered and that are used for the same purpose in both donor and host do not need premarket approval. Products that do not fall under this umbrella, though, are regulated as drugs, biologics or devices. In this case, the drug must be tested on animals before the company can submit an application to the FDA. The FDA then reviews the application to assure that the proposed studies/clinical trials do not place human subjects at unreasonable risk of harm.
From there, the drug is approved for Phase 1 testing with 20-80 healthy volunteers. Phase 1 emphasizes safety. Phase 2 then involves hundreds of patients with a focus on effectiveness. Afterwards, the FDA and sponsors discuss how large-scale studies in Phase 3 will be done. Phase 3 involves thousands of patients and studies different populations, dosages, and the use of the drug combined with other drugs. After another review meeting with the FDA and sponsors, the company submits an NDA, formerly asking for approval for marketing in the US. The FDA has 60 days to review the application.