Autologous Stem Cell Injection

What Happens Before Injection?

Before the injection procedure, the patient must first come for a consultation visit, during which the stem cell therapy is planned and treatment options are discussed with the patient. A blood sample may also be obtained during this initial visit for compatibility and infectious screening purposes, all though it is not strictly necessary for autologous injections.

When the patient comes in for the stem cell therapy, the procedure consists of two parts; extraction and injection. The extraction of stem cells requires bone marrow aspiration, conducted in-house. The procedure can be painful, and rest is necessary to ensure the process goes by smoothly. Once the bone marrow aspirate is obtained, it is processed in our GMP-compliant laboratory according to FDA standards of minimal manipulation; the bone marrow aspirate is centrifuged to extract the stem cells that constitute the injection.

What Happens During Injection?

Injection of stem cells into a desired location is done by professionals – having the stem cells placed in a bloodstream near the location is nuanced job. The process requires precision to ensure the stem cells are concentrated in the necessary tissue to ensure revival. Local anaesthetics may be used, and there is only one injection conducted.

What Happens After Injection?

After injection, the patient will be monitored for any immediate effects, and then they are free to go. It is advised to not take any anti-inflammatory medications after the injection as well, and though it is uncommon, pain at the injection site may be present. Sharp pain should be counteracted with ice, while deeper pain should be treated with the application of heat.

Of course, the bone marrow aspiration procedure can have more lasting effects painwise, and we at Altogen Labs are working on our homologous injection therapy to eliminate the procedure entirely. Antiseptics should be used to prevent infections at the incision site, and further pain medication may be necessary.

Any longer term side effects should be monitored and discussed with a medical professional, but overall, the benefit from the stem cell injection will be gradual. Clinical studies investigating stem cell treatments usually note that the main benefit from stem cells is present around a year after the initial injection. Patience will be important, but safety is of paramount concern – patients should have regular checkups, and confirm that progress in treatment is being made.

In the case that a patient develops a problematic condition, they should reference the stem cell therapy when consulting with their physician; although the stem cell therapy is highly unlikely to result in any negative consequences, it can affect what treatments will be effective in the patient.

Usually patients will experience gradual relief from their damaging condition, but it is always important to be cautious in daily life. A stem cell injection is not a cure to all diseases, and it does not necessarily protect a patient from infections or other external factors. After all, stem cell therapy aims to help the body repair itself, and not to give it new capabilities. This repair process is beneficial, bringing about long-awaited relief from impairing conditions.

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.