Cell therapy is the use of cells and tissues to regenerate, repair, and in some instances, even enhance human health. Traditionally, the modern medical system has relied on a pharmaceutical-based approach. This led to the rise of the U.S. Food andDrug Administration (FDA) which was founded in 1906, making it 111 years old this year. Unfortunately, our approach to human health has not experienced a dramatic shift over the past 100+ years, and as a society, westill tend to rely on a drug-based approach.
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Although variations exist, drugs generallywork by binding to receptors on the cell surface or by exerting an enzymatic effect to regulate the rate of an internal chemical reaction. Pharmaceuticals can frequently modulate the human system with great effect, but rarely do they have the capacity to regenerate or restore entire tissues or systems within the human body.
In contrast, cell therapy works because cells arepowerful factories that can exert therapeutic effects through a wide range of strategies, including honingto sites of injury, exerting paracrine effects, and in some cases, differentiating into new types of cells and tissues.This versatility makes cell therapy extremely powerful and gives it the potential toreverse previously untreatable diseases.Needless to say, it is an exciting time in history.
For this reason, cell therapy or more likely, cell therapy in combination with pharmaceuticalswill be the future of human health.
Below, we profile eight strengths of cell therapy that will propel the future of stem cell therapy into the medical mainstream.
Cell therapies have the potential to treat disease conditions with no known cure. There are many conditions that are nowincurable, such as vision loss. While there has never been a treatment capable of reversing permanent vision loss, clinical trials are investigating the potential to restoreit.
Specifically, there is a cell therapy clinical trial underway at theRIKEN Center for Developmental Biology (Japan), in which autologous iPSC-derived retinal pigment epithelial (RPE) cells are beingtransplanted into human patients with age-related macular degeneration. Although the trial was initially suspended due to safety concerns, it is now being resumed using allogeneic iPSC-derived RPE cells.
Cell therapies also have the potential to reverse and repair diseases that have traditionally only been managed. For example, current drugs can slow the decline in functionality associated with multiple sclerosis (MS), but cannot stop or reverse the symptoms. However, in April 2016, a Phase I Clinical Trial conducted by the Tisch MS Research of New York (TMSRCNY) announced positive results from a FDA-approved Phase I stem cell trial for MS.
In this trial, MS patients received multiple spinal injections of neural progenitors derived from bone marrow mesenchymal stem cells (called MSC-NPs), and it was the first time in human history that a treatment method demonstrated reversal of established disability in MS patients. Tisch MSRSN is now pursuing a Phase II clinical trial to explore the potential of stem cells to reverse MS.
Cells are powerful factories that are naturally present within the human system. Moreover, some cell types have intrinsic mechanisms that can assist with promoting repair. As we like to say at BioInformant, We arenot made of drugs, we are made of cells.
For example, mesenchymal stem cells (MSCs) can home into sites of injury, synthesize and secrete a variety of macromolecules toexert paracrine effects, and influence their local microenvironment. MSCs can also take up exogenous DNA and keep introduced genes, an attribute that may allow the use of the cells in the therapeutic delivery of molecules to target regions of the body.
Additionally,MSCs can form a variety of cell types in the laboratory, including those of both intra- and extra-mesenchymal lineage. These cell types include: fat (adipocytes), bone (osteoblasts), skin (dermal cells), nerve (neural cells), cartilage (chondrocytes), muscle (skeletal myocytes), tendons (tenocytes), marrow stroma, ligaments, and more.
With potentially hundreds of therapeutic cell types to explore, being a natural component of the human body is clearly a therapeutic advantage.
For many disease conditions, such as diabetes, patients are required to take a prescription on a daily basis. A cell therapy approach would substantially reduce the healthcare costs of this disease by providing a one-time (or limited-time) treatment. Similarly, cell therapy approaches to pain management would substantially reduce the costs of opioid-based pain medications. There are many examples of how cell therapy treatments could make pharmaceutical treatments obsolete.
Another strength of cell therapies is that it could overcome donor shortages. For many disease conditions, the only known cure is a tissue or organ transplant. Examples of transplanted tissues and organs include the heart, kidneys, lungs, pancreas, pancreatic islet cells, and more. However, if a cell therapy approach could convert a diabetic patients own tissue into insulin-producing cells, it would overcome the problem of donor shortage and remove the risk of transplant rejection.
For this reason, the following companies are exploring cell-based solutions to diabetes:
The same principle is true for every type of tissue and organ transplantation.
Cell therapies have the potential to replace many risky, costly, and invasive surgeries. For example, the Regenexx treatment pioneered by Dr. Chris Centeno is an autologous same-day, minimally manipulated MSC procedure that is legal in the U.S., because it meets the FDAs requirements for not requiring a clinical trial process.
In this cell therapy procedure, a proprietary two fraction isolation, which is a buffy coat plus another source of stem cells within the bone marrow, is administered to a patient in a 3-step process. The first step is a pro-inflammatory injection for which Regenexx received a recent patent. The second step is implanting the stem cells via precise guidance. The third step is a fertilizer type step, adding in platelet-based growth factors.
Interestingly, this cell-based procedure is capable of repairing most ACL tears that would have traditionally been treated with surgery. With an estimated 100,000 ACL surgeries performed in the U.S. each year, this cell therapy alternative represents a paradigm shift. The Regenexx procedure may also prevent other surgeries, such as shoulder rotator cuff tear surgeries, hip surgeries, and more.
Most surgeries create an enormous amount of inflammation (swelling) and fibrotic activity (scarring). Therefore, the future of surgery will likely involve combining the structural elements provided by a surgeons skills with the anti-inflammatory and anti-fibrotic elements of cell therapies. The most likely solution is that autologous or allogeneic MSCs will be administered to the patient immediately post-surgery to support healthy regulation of the patients response to surgery. The reason for use of MSCs is that they are safe, easily sourced from adipose tissue and bone marrow, and thoroughly documented to have strong anti-inflammatory and anti-fibrotic properties.
Currently, the Mayo Clinic is testing the use of autologous cord blood cells for thetreatmentof HypoplasticLeft HeartSyndrome (HLHS). It isexecuting is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of HLHS children undergoing a scheduled Glenn surgical procedure.
The investigators are doing this study to find out if autologous stem cells from the individuals own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment to support surgical management of HLHS.
Cell therapies also have the potential to work synergistically with pharmaceutical drugs. For example, evidence indicates that intravenous administration of MSCs may improve several metrics of cardiac function, potentially making them a synergistic to medications traditionally prescribed to cardiac patients, such as amlodipine, diltiazem, and felodipine, and others.
One company leading the way is the area of cell therapeutics used in conjunction with pharmaceutical drugs is Stem Cell Medicine Ltd. in Israel. As Frida Grynspan, VPof R&Dand Site Manager for Stem Cell Medicine Ltd., told BioInformant in aninterview, Stem cells used in conjunction with pharmaceuticals are the future of medicine. Not surprisingly,Stem Cell Medicines mission is to develop and commercialize cellular therapies in combination with pharmaceutical products to be used for tissue repair and for the treatment of inflammatory, immunological and neurological disorders.
Do you have other reasons why cell therapy is the future of medicine? Mention them in the comments section below and well add them when we update thispost.
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8 Reasons Cell Therapy is the Future of Human Health
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