How do Stem Cells work Naturally?
Adult stem cells are found in almost every part of the body, and they serve as a backup reserve for specialized cell types (e.g. liver and retinal cells) in case those specialized cells need to be replenished. But there are also stem cells that only exist during development, such as embryonic and cord blood stem cells, which grow into entire organs and tissues. Cord blood stem cells, in particular, are often cryogenically stored in case they need to be injected back into an individual. When this injection occurs, the stem cells start to be active and help rebuild damaged tissues.
In essence, stem cells are the building blocks of the body, and they can be used to repair different parts as well. With time, stem cells start to number fewer, leading to one possible cause of aging. Still, damaged tissues and cells are filled-in for by stem cells that are located all around the body. One of the current areas of stem cell research is how stem cells change throughout life; those present during embryonic development are far different than adult stem cells, and finding out the differences may be the key to inducing adult stem cells (technically called induced pluripotent stem cells) to become the progenitors of other cell and tissue types.
How are Stem Cells used in Medicine?
Cord blood stem cells and bone-marrow transplantations are FDA-approved therapies for blood-related diseases, such as leukemia. The injected stem cells can often help combat invasive conditions and replace desperately-needed tissues and cell types, which in turn cures degenerative diseases and helps the body recover. In context of leukemia, chemotherapy is used to kill off many white blood cells (both cancerous and normal), and then stem cells are injected, which turn into the missing cell types and help restore the body’s immune system. This process works, and was the first one to successfully undergo clinical trials as a stem cell therapy.
Other blood diseases can also be cured by the injection of stem cells, and bone marrow transplants (which contain stem cells) are the most common method by which such therapies are enacted. The Altogen Labs therapy is an example of such a technique – although we take a few steps further to ensure that the obtained stem cells are both viable and compatible with the tissue types that are being treated.
Currently, hundreds of other stem cell therapies are undergoing clinical trials for FDA approval, however less-complicated stem cell therapies do not require FDA approval, and have had widespread acceptance on a global scale. For example, cord blood stem cell injections, where the stem cells are not altered in any way, are commonplace for the treatment of osteoporosis and other bone-related ailments that are more prevalent with age. Other approved procedures include the autologous implantation of bone marrow stem cells; patients arrive at a medical facility, where a sample of their bone marrow is extracted and reimplanted at a different location, with the aim of having stem cells be active in a damaged tissue or organ.
Altogen Labs current research into homologous injection therapy involves the use of cord blood stem cells, although there are many safety points that must be addressed. In advance of offering the therapy, we are taking the time to formalize rigorous safety procedures, especially in context of obtaining the cord blood and evaluating it for compatibility with a patient.
How are Stem Cells Used in Altogen Labs Therapy?
Altogen Labs autologous injection stem cell therapy uses a patient’s own stem cells. These are obtained from the blood marrow during and in-person procedure, and the cells are then filtered before being injected back into a desired location. Because of FDA regulations, we are only able to re-inject obtained stem cells into tissues surrounding bone. This includes joints, such as the hip, and various connective tissues, for example those around the spine.
How are Stem Cells Obtained for Medical Use?
Before they can be implanted into a person, stem cells need to be obtained in an ethical manner from competent donors. While adult stem cells can be difficult to derive, they are guaranteed to be compatible with the same patient from which they were obtained. Altogen Labs procedure requires bone marrow aspiration to retrieve such stem cells, and they are afterwards filtered to ensure only the viable stem cells remain in a concentrated dose for the injection.
Alternative means for obtaining stem cells include the retrieval of cord blood stem cells at birth, with no harm, pain, or damage to the mother and her child. Of course cord blood is obtained with the consent of the mother, and the procedure poses no ethical dilemmas as it does not impact the survival of any viable human being. Simply put, after the umbilical cord is severed, blood from the cord is obtained by a needle. Usually the cord is simply discarded, but harvesting the cord blood can help someone else recover from a debilitating condition.
Currently there are other approaches to extract stem cells, though they tend to be generally more painful and intrusive to the patient. Though our current bone marrow aspiration procedure involves making a hole in a bone (usually the hip) to remove a sample of bone marrow, which can contain high concentrations of stem cells, it can be painful to a patient. One of the more promising approaches is liposuction, where fat tissue is removed from a patient. Such fat tissue contains stem cells (albeit in low amounts) that can then be extracted and reimplanted back into the same patient. However, the necessary filtration process of the fat tissue to remove the stem cells so far requires clinical trials, and as none have been completed, commercial liposuction-based stem cell therapies are not allowed by the FDA.
Are Stem Cell Treatments Safe?
Yes – if done properly. No – if done carelessly. Every single person originates from a stem cell, so of course stem cells can be beneficial. That being said, some clinics advertise stem cell injection services that can result in harmful effects; blindness, tumors, and other adverse conditions have been known to occur from improper stem cell procedures. In particular, homologous injection procedures (which Altogen Labs is developing) can be dangerous if the injected stem cells are not screened for compatibility prior to the injection. This can result in damage to the patient and liability concerns, all of which should be avoided. Our current development is focused on ensuring patient safety with a homologous injection. In the meantime, our autologous injection service poses no incompatibility risk to the patient, and is available for purchase.
The FDA heavily regulates stem cell treatments, and we at Altogen Labs make sure to comply with all regulations pertinent to our services. In our current homologous injection research, all of the cord blood derived stem cells have been screened for a whole swath of infectious diseases, and both the patient and the donor are matched genetically to make sure the stem cells will not cause a negative immune reaction (this testing is called HLA-typing). The matching of the donor to the patient is a crucial step in homologous stem cell implantation, as studies have shown that non-matching stem cells (or at least those that are significantly different) do not help with curing diseases, and lead to comparatively higher rates of mortality. Any stem cell treatment provider that does not guarantee the HLA-typing of stem cells on a genetic level is risking the life of the patient. In our developing homologous injection therapy, we screen all of the recommended HLA loci by the National Marrow Donor Program, helping ensure the success of stem cell implantation.
It is worth noting that safety does not necessarily correspond to effectiveness; clinical trials of stem cell therapies have observed mixed results on occasion. Current research suggests that higher doses of concentrated stem cells that are matched to the patient are more likely to result in beneficial effects. We at Altogen Labs make sure our therapy maximizes the potential for benefit, while minimizing the chances of health problems after the stem cell injection.
How does the FDA Regulate Stem Cell Treatments?
The FDA has strict guidelines relating to the usage of stem cells in treatments and how this may be done. One of the more stringent requirements is that stem cell treatments that more than minimally manipulate stem cells must undergo clinical trials before being offered on the market. For example, a stem cell treatment that retrieves stem cells from adipose (fat) tissues and in the process destroys the structural aspects of the tissue would require clinical trials, but a stem cell treatment that obtains stem cells by filtration from the blood without damaging any biologically-relevant components would be (and is) allowed without clinical trials.
The FDA also requires that donors of any tissues are screened for infectious diseases; those that test positive may not be donors for any cell-based therapy. These infectious diseases are; Human immunodeficiency virus, types 1 and 2; Hepatitis B virus; Hepatitis C virus; Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease; Treponema pallidum; Human T-lymphotropic virus, type I; and Human T-lymphotropic virus, type II. This is not required for Altogen Labs current autologous stem cell therapy, as the donor is the patient, and compatibility is thus guaranteed.
In our upcoming homologous injection therapy, we go further than FDA regulations in making sure our treatments are safe – abiding by the recommendations of the National Marrow Donor Program, we make sure that stem cells are compatible with a patient on a genetic level through HLA-typing, preventing immune-based rejection, reducing chances of side effects, and boosting the potential of our stem cell implantations.
Stem cell therapy providers must register with the FDA and make sure that quality standards are embedded in the process of the therapy. Detailed protocols, procedures, and nuances must be formalized in advance of any kind of injection. Checking for such FDA registration is important, as stem cell therapy providers that do not register with the FDA are violating federal law, and pose a substantial risk to public health.