Stem cells are the most versatile kind of living cell – they can evolve (the technical term is differentiate) into other kinds of cells, such as neurons and skin cells. Every animal grows from a stem cell; the fertilized egg, which divides into multiple cells that can further replicate and grow to form everything from a kidney to an ear, eventually leading to a fetus. The stem cells that are found within the embryo during pregnancy are called embryonic stem cells, and they are the ones that are necessary for an organism to grow. However, there are other kinds of stem cells as well; as an organism grows, stem cells are retained in the blood marrow and other tissues in case of damage to body parts.
When an organism is harmed and cells are killed, platelets in the blood guide stem cells to the damaged area, for example a toe, and the stem cells fill in the spots of the dead cells to make the tissue functional again. Embryonic stem cells are the only natural ones that can turn into any other kind of cells. Stem cells that are kept in an organism throughout life are called adult stem cells, and have limited capabilities to turn into other kinds of cells (for example, they might be able to turn into blood cells, but not neurons). Adult stem cells are a subject of active research, as they may help lead the future in regenerative medicine. Currently, regulatory limitations on stem cell therapies prevent companies from offering non-homologous injections of stem cells that do not originate from a given patient.
Medical Applications of Stem Cells
Many diseases are caused by a lack of stem cells present in an organism to fix damaged tissues, and one of the most potent medical practices currently available is the transfusion of stem cells (almost like a blood transfusion) from one person to another, or from one person to themselves. When stem cells are taken from another person, they are usually encountered in collected bone marrow, which, for example, when placed into leukemia patients can help overcome leukemia and lead to a healthy immune system. When stem cells are taken from the same person, they are called autologous, and can then be placed back into damaged tissues (such as a knee joint) where the stem cells repair and help regrow aging organs. Stem cell therapy, based on this repair process, is a highly-regulated medical practice that has been developed (and is still developing) over several decades.
Current research into medical applications of stem cells focuses on making accessible stem cell therapies that do not require invasive surgical procedures like bone marrow aspiration. These novel therapies are undergoing clinical trials, and may soon become available commercially. Although simple stem cell therapies have been available for some time now, more advanced ones are still being evaluated for uses in humans.
Some of the more promising stem cell therapies currently in clinical trials include those that extract stem cells from fat tissue, grow in the laboratory, and modify them in special ways to make sure they are active when inserted back into a patient. Other interesting therapies aim to extract stem cells and help them turn into a given tissue type before implantation back into a patient – that way cancers cannot physiologically form, and the implanted cells are guaranteed to act as a given tissue type. Overall, stem cell therapies are rapidly advancing, but the intricacies of each have required years of controlled testing and evaluation.
Side Effects of Stem Cells
Side effects from stem cell injections usually occur if the stem cells are taken from another person who hasn’t been screened for infectious diseases and immune compatibility; because every single person is different, it is possible that a recipient patient may reject the stem cells, foregoing any beneficial results. Another problem can occur if embryonic stem cells are injected; since embryonic stem cells can turn into any other kind of cell, they can lead to the formation of a teratoma – a cancer consisting of multiple tissue types. To avoid this, usually adult stem cells are used, and they are selected to be compatible with a given patient, limiting the risk of rejection and teratoma formation.
A common low risk option for stem cell injections is autologous stem cell therapy (stem cells taken from a person to be injected back into the same person), as a patient will not reject their own cells, and it is unlikely for teratomas to form. However, there are other safe sources of non-embryonic stem cells that pose less surgical risks than autologous therapies. These sources include amniotic fluid and cord blood, which pose less of an immune risk and are also easy to derive (without harm done to any person).
The general side effects of stem cell injections are usually limited to pain at the injection site, but such effects are temporary and are associated with the injection procedure and initial adaptation rather than stem cell activities. Longer term side effects will only occur if the stem cell therapy was conducted improperly, and such effects require prompt medical attention with subsequent treatment procedures.
Ethical Controversies Involving Stem Cells
There has been a lot of discussion about the ethics behind embryonic stem cells; as the cells come from a developing embryo, harvesting the cells necessarily kills a possible future fetus. However, adult stem cells, those from cord blood, and autologous stem cells are not derived from an unborn individual, and have been used in laboratories for years without ethical quandaries. Retrieving stem cells from amniotic fluid (which comes from the amniotic sac during pregnancy) is considered to be a generally ethical procedure, so long as the amount of fluid removed is minimal and does not affect the viability of the fetus.
Other ethical concerns have been raised about stem cell therapies that have not been tested in clinical trials; companies that provide stem cell injection services without FDA registration have been known to offer unsafe stem cell therapies that have led to blindness and cancer in some patients. It is important that stem cell therapies have minimized risks for a patient, and though cheaper (and less safe) alternatives are more lucrative financially, they can lead to devastating consequences and should likewise be avoided.
Altogen Labs Stem Cell Services
At Altogen Labs, we’re developing stem cell injection services for patients while researching possible new therapies; our stem cell therapy is driven by a dedication to safety, and we will screen stem cells before injection, selecting those with the lowest chances of leading to harmful effects. Our current therapy is classified as an autologous injection of human cells and tissues – the therapy involves a medical procedure using bone marrow aspirate from a patient, which is then filtered and reinjected into another part of the patient. The procedure does not involve stem cells obtained from a separate donor, and hence there are no incompatibility concerns.
We are currently researching and seeking to offer less surgically-intrusive stem cell therapies, one of which relies on the homologous injection of cord blood samples, obtained from human patients that have been screened according to FDA regulations, which we then carefully examine and filter to leave stem cells that are compatible with a patient’s immune system. We conduct additional procedures to help boost the effectiveness of stem cells, and the injection takes place during one single procedure conducted by medical professionals at a regulatory-compliant facility. Based on the condition and resources of the patient, a double dose of stem cells may be used, as this has been shown to result in better long term outcomes of stem cell injection.
Custom options for our stem cell therapy are discussed during the initial consultation; special injection procedures, compatibility with chemical treatments, and other individual cases are addressed. Should there be a need for any kind of specialized setup, we are prepared to accommodate it.
Process of Altogen Labs Autologous Stem Cell Treatment
Our current therapy involves one surgical procedure (taking place during one patient visit) where stem cells are obtained from the patient’s bone marrow. In advance of such a procedure, the patient is consulted on their ailments, and possible treatment options are discussed. As every patient is different, the treatment may have varying effects. Additionally, the location of the stem cell injection has a substantial effect on the efficacy of the treatment. Overall, the patient’s responsibilities are limited to an in-person visit, during which stem cells are extracted, filtered, and injected into another part of the body.
On the laboratory end, Altogen Labs employs state-of-the-art diagnostic methods for evaluating the capacity of obtained stem cells to be viable in autologous injections. During the in-person procedure, obtained bone marrow aspirate is filtered, and is assayed for the presence of viable stem cells. Additionally, compatibility metrics (relating to the cell type and origin) are evaluated to ensure that the injection is successful.
After the in-person procedure, the patient is free to leave, and subsequent checkups are scheduled to ensure that the therapy is moving along smoothly. Common issues with stem cell therapy include pain and discomfort, which can be addressed with medications. Should larger issues be discovered (for example tumor formation) these must be addressed immediately, depending on the severity of the condition.
Process of Future Homologous Stem Cell Treatment
As we are researching homologous therapies, we have developed rigorous protocols that will be used for homologous injection services. The process of a homologous stem cell treatment begins with consultation with a patient, during which malaise conditions are identified and treatment options are discussed (a blood sample is also obtained for compatibility purposes). The blood sample is analyzed genetically to determine the immune characteristics of the patient. Next, cord blood samples are obtained, screened, and processed to make sure the remaining stem cells will work properly in the patient. Once the stem cells are ready, the patient comes over for a nurse-assisted injection, and then they are free to go. Afterwards, the patient is monitored and any possible side effects are addressed, with the overall benefit maximising after around a year.
The patient’s responsibilities will be limited, as most of the work takes place in our laboratory. The most important aspect for the patient is to get the details for their chosen stem cell therapy and check for regulatory compliance. If all of the procedures have safety embedded in their processes (as mandated by the FDA) then the stem cell therapy is likely to be risk-free. The patient also has the responsibility to monitor their condition after the stem cell injection, as side effects can vary, and problematic conditions should be addressed immediately.
Stem Cell Regulation
Why Regulate Stem Cells?
With their myriad of promises, stem cells may seem like a lucrative and simple solution to many chronic illnesses. Risks, nonetheless, can be substantial and require both federal and state regulation to mitigate the chances of failed treatments. Clinical trials are necessary for unproven techniques, while autologous injections should only be conducted by regulatory-compliant facilities. Recently, the FDA identified a dozen stem cell clinics that were not abiding by regulations and had non-compliant facilities, leading to dangerous consequences for unassuming patients. These incidents show why regulations must be in place, and what consequences they should address.
Who Regulates Stem Cells?
Both on the state and federal levels, various public health agencies have the authority to enforce regulations on medical procedures. The FDA has authority to regulate stem cell procedures as a consequence of the Public Health Service act, which gives the agency power to enact guidelines for medical procedures involving human cells and tissues. In Texas, where Altogen Labs’ core facilities are located, state law also affects stem cell procedures. Although Texas has not passed laws substantially more stringent on stem cell therapies than Congress has, it still has its own regulations that affect medical practice.
What is the Charlie Act?
The State of Texas enacted the Charlie Act in 2017, which allows for investigational stem cell therapies that are currently undergoing clinical trials to be implemented in patients with chronic diseases that have received physician approval, with adult stem cells derived from the patient (i.e. autologous therapies). This law has allowed many clinics to begin clinical trials and enroll patients to be participants. Although this law has shown promise in expanding access to stem cell therapy, it does not plainly allow commercial providers to sell stem cell therapies undergoing clinical trials to any patient. A patient must first qualify, after which they may be selected for a stem cell injection procedure. Fortunately, this law only affects stem cell therapies undergoing clinical trials – autologous therapies for generic patients that minimally manipulate stem cells are allowed under federal law.
Federal Regulations of Stem Cell Procedures
In recent years, stem cells have gained notoriety as potential cures to a multitude of degenerative diseases. This has come with much more attention by the FDA, and a consequent increase in oversight of stem cell clinics. Though federal regulations have not changed, the FDA’s interpretation has. The FDA is allowed to interpret these regulations, and hence have an enormous influence over what procedures stem cell clinics may conduct without a need for clinical trials.
There are many technical details outlined by the FDA regarding stem cell manipulation. A key concern of the agency’s regulations has been the processing of stem cells after they have been obtained; should the stem cells be grown before injection, they could gain unprecedented characteristics that might negatively affect patient outcomes, or if they are treated with some growth-stimulating chemicals, they could result in tumor growths. With these important concerns at stake, the FDA has developed the ‘minimal manipulation’ standard. Though there are many, many components of the definition of minimal manipulation (the FDA’s official stance on the topic takes up 28 pages), it comes down to stem cells being kept in their original state. For example, fat tissues extracted from a patient cannot be crushed for the stem cells to be released, as this would damage the inherent structure that the stem cells were originally part of. For bone marrow aspiration procedures, the stem cells are already infused in blood, and hence the extraction only minimally manipulates the cells.
Is Altogen’s Autologous Therapy Compliant with Regulations?
Yes. Autologous therapies involving bone marrow aspiration that minimally process stem cells are in accordance with federal regulations. There are, of course, many more regulations involving medical facilities, practice, record-keeping, etc. Altogen’s autologous stem cell injection procedure is compliant with the relevant sections of the code of federal regulations, and does not require clinical trials. The procedure is marketed nationwide, with varying degrees of success based on the practices of given clinics.
With the FDA’s increasing presence in the field, it is becoming clear that many providers have not been following proper practices, leading to dangerous consequences for patients. Altogen maintains a strong commitment to abiding by all relevant regulations, regardless of the efforts and investments required. Our priority is the patient, and while our developing homologous therapy will involve far more regulatory aspects, our current autologous therapy is modelled after successful approaches by well-established clinics, helping boost the chances of its success.
Costs and Limitations
Stem cell therapy is expensive; the costs of running laboratory work are high, and the resources necessary for successful injection are a rarity. We at Altogen Labs try to make sure that the injected stem cells will not lead to teratoma formation and other vulnerabilities, and although cheaper services may be quicker, they run the risk of leading to life-threatening cancer formation and other rejection-based side effects that ruin the prospects of stem cell therapy.
Checking for FDA registration is always a prerequisite to enrolling in a stem cell therapy program, and regulatory compliance is one of the most significant factors that can affect the safety of medical procedures. At Altogen Labs, we make sure to address all nuances of patient safety and good laboratory practice, helping ensure that our stem cell therapy services benefit every patient. We abide by the recommendations of the National Marrow Donor Program, and we take all possible precautions to ensure patient safety. With patient health being of paramount importance, Altogen Labs stem cell therapy can help revive and rejuvenate, bringing patients a welcome relief from their ailments.