Collection and Processing of Stem Cells

Where are Stem Cells Found?

There are many kinds of stem cells – some of them are found in adults, while others are only found in developing embryos. Nonetheless, stem cells persist in a variety of bodily tissues, and differ in terms of their accessibility. Stem cells found in the brain are difficult to extract, while those located in the umbilical cord (after it has been severed during birth) are very easy to obtain. Stem cells are also present in different amounts in tissues; the concentration of stem cells in bone marrow is far higher than that found in adipose (fat) tissue. Different stem cells are found in different areas of the body, and finding the right ones requires precision in laboratory protocols.

In Altogen Labs autologous stem cell therapy, the stem cells come from the bone marrow, where they are present in relatively high concentrations. The extracted material from the bone marrow, called bone marrow aspirate, also contains a variety of other cell types and materials, requiring filtration to isolate the end injection volume.

Why does it Matter Where Stem Cells Come From?

Stem cells from different parts of the body are suited for different tissue types; stem cells found in the liver will be apt at turning into liver cells, but will be unable to turn into neurons and skin cells. As such, having stem cells from the right part of the body to treat a given condition is crucial for overall effectiveness. Because Altogen Labs stem cell therapy extracts stem cells from the bone marrow, they are more suited for growth into fibrous, connective, and bone tissues. This means, for example, that they will be better for treating arthritic symptoms than for resolving gastric damage.

However, embryonic stem cells and those from early-stage development (such as cord blood stem cells) are able to turn into many types of cells, and can thus lead to the repair of many tissue types. There is a lot of current research investigating how stem cells can be made to replace any given tissue type, but there is no guaranteed way so far to do so. For current stem cell therapies undergoing clinical trials, the stem cells are usually obtained from the same tissue as is the target tissue to be repaired. Some stem cells, like mesenchymal stem cells, can turn into several tissue types, and can likewise be injected into a joint or the bloodstream in order to elicit benefits.

Where Do Stem Cells for Homologous Injections Come From?

The stem cells used in our developing homologous therapy are obtained during birth from the umbilical cord after it has been severed, meaning that the blood in the umbilical cord no longer flows to the child, and is no longer returned to the mother. Hence, there are no ethical dilemmas with obtaining the cord blood, as the process does not affect the mother or the child.

The mother gives permission to obtain the cord blood, after which it is frozen or directly delivered to Altogen Labs GLP-compliant laboratory in Austin, Texas. The cord blood itself contains a variety of cell types, ranging from simple red blood cells to leukocyte progenitors. The cord blood, when frozen, is done so with several preservative compounds that prevent ice crystals (made out of water) from puncturing the cells, which would kill them. Usually, a single unit of cord blood will be around 100 milliliters in volume.

For double-dose stem cell therapies, two cord blood units are obtained for one injection. The units are not mixed together, and are processed separately, but are combined before injection into the patient. This process is known to boost the efficiency of stem cell therapy, and can substantially improve overall results.

How are Stem Cells Processed After Collection?

Because successful stem cell injections require both a high dosage of stem cells and compatibility between the donor and the patient, the raw cord blood samples are processed in a laboratory setting. There are hundreds of steps involved in the processing of cord blood after it has been obtained, but there are a few general procedures.

The cord blood is first genetically analyzed for several immune characteristics recommended by the National Marrow Donor Program, after which the compatibility with the patient is determined. This is necessary in order to ensure that the stem cell injection will not cause a negative immune response, which would kill off the injected stem cells.

Afterwards, non-stem cells are mainly filtered out by a chemical technique involving the clumping together of red blood cells, which then settle down, leaving stem cells in a plasma matrix. This concentrates the stem cells, which research has shown also improves the long-term outlook for patients.

The remaining solution of unaltered stem cells is then injected into the patient. Higher and more concentrated doses of stem cells (even from several donors) have been historically observed to result in better outcomes for patients, and depending on the patient’s wishes, multiple stem cell volumes may be combined before injection.

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.