What Happens Before Injection?
Although the homologous injection procedure is not available yet, it will require patients to come in for an initial visit during which a blood sample must be collected. This blood sample is then used to determine the histocompatibility between the patient and the donor stem cells obtained from cord blood.
The hundreds (if not thousands) of steps needed to be completed before the stem cell injection explain why stem cell therapies are regulated by the FDA, and why they are so complicated to enact. There are lots of procedures that need to completed with safety and sterility in mind to ensure that the injection helps the patient. Altogen Labs takes every step seriously, and makes sure that all proper documentation and registration is complete before any step is completed.
What Happens During Injection?
The injection procedure is relatively straightforward – the stem cells are injected into the bloodstream near damaged tissue. This injection does not require anaesthesia (only a local anaesthetic if necessary), and does not take much time.
A relatively wide needle is used for the injection, as smaller needles may crush the stem cells, rendering them useless. During the injection visit, pre-frozen stem cell samples are thawed and mixed with special compounds to make sure that the stem cells remain active after they are injected into a patient. This thawing procedure is quick, and immediately after thawing the stem cells are injected.
What Happens After Injection?
As with the autologous injection, side effects must be monitored, particularly in context of the injection site. However, the added benefit of the homologous therapy (when it becomes available) is the lack of a bone marrow aspiration procedure, which reduces the pain of the procedure considerably.
Unlike an autologous injection, the homologous injection uses the stem cells of another individual. Though screening measures are in place, there is always the risk of incompatibility between the donor and the patient. Regular screenings are necessary to ensure that the injection procedure did not lead to any transferable diseases or conditions. As we develop our homologous injection procedure, we are making sure that all relevant measures are in place to reduce such a risk. Nonetheless, having the injection site monitored up to a year after the injection is necessary in case of the development of a malignant condition such as a tumor.
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.