FAQ’s on Regenerative Medicine - Stem Cell

and Exosome Therapy

 

What is Regenerative Medicine?

Regenerative Medicine is therapy designed to repair and regenerate damaged body tissues such as tendon, ligament, cartilage, bone, organ, nerves. It’s a different approach than the way medicine has been offered for centuries, where treatments and medications are typically a “band-aid” approach. The concept of Regenerative Medicine is to shift the paradigm of patient therapy into something that can assist with tissue repair, rather than just suppressing symptoms (like a narcotic). Traditional therapies such as cortisone injections simply do not offer healing potential, and actually make patients worse. So Regenerative Medicine uses substances that provide potential to work on the healing process for these injuries by providing building blocks known as stem cells along with exosomes, growth factors and platelets that spur the body’s natural healing processes to ramp up.

 

What are Stem Cells?

Stem cells are made by the body’s bone marrow and are able to differentiate into several different cell types. They are a veritable “blank slate”. They can replicate into more unspecialised stem cells, or they may react to the environment in which they are placed by receiving signals from that environment telling them which differentiation “pathway” to go down. This may be to turn into a skin cell or muscle, cartilage, tendon, bone, red blood cell and many others depending on the type of stem cell. By ramping up production of the cells needed to stimulate repair, having extra supply in the area can provide the difference between an inadequate result and one that regenerates perfectly.

 

What are the types of Stem Cells?

There are two basic types of stem cells. The first is known as pluripotent stem cells (also known as embryonic stem cells). These can turn into any kind of cell in the body. Embryonic stem cells are derived currently from either an aborted foetus, or a left-over embryo after an IVF procedure. Currently, embryonic stem cells are not safe to offer to patients, as they commonly result in rejection, or possibly tumour formation.

 

The second type is termed limited stem cells (also known as adult stem cells). These stem cells come from either:

1. Autologous source – the patient’s own bone

marrow or fat tissue.

2. Birth tissue – placenta, amniotic fluid, umbilical

cord tissue or blood.

3. Menstrual blood

4. Wisdom teeth

 

Healthspan Medical does not work with embryonic stem cells, only adult stem cells. There are about ten different kinds of adult stem cells. 

 

We use two separate kinds at Healthspan Medical:

 

1. Hematopoietic Stem Cells – these are found in

human bone marrow, and umbilical cord blood and

are able to differentiate into several cell types.

 

2. Mesenchymal Stem Cells (MSC’s) – MSCs have

been isolated from placenta, adipose tissue,

lung, bone marrow and blood. They are able

to differentiate into many different cell types

while also assisting with the human immune

response.

 

Does Insurance cover regenerative

procedures?

 

Insurance does not currently cover regenerative medicine procedures for the most part in any country. There are certain instances in surgery where there are codes for the various procedures. But by and large, the procedures are considered a fee for service.

 

Can stem cells be rejected?

The umbilical cord mesenchymal stem cells used by Healthspan do not get rejected. We get frequently asked if there needs to be a related donor or whether a patient needs to have an autologous umbilical cord blood sample.

 

The answer is no. The donor stem cells from the umbilical cord tissue are called “immunologically privileged”. They do not have MHC-2 Markers, so the recipient does not recognise them as foreign. Therefore, no rejection occurs.

 

If you consider treatment at a clinic offering pluripotent stem cells (e.g. embryonic stem cells or induced pluripotent stem cells), you are putting yourself at risk. Pluripotent stem cells from those sources are not ready for clinical use and typically get rejected, which can be very serious.

 

Are any babies harmed during the acquisition of stem cells that Healthspan Medical uses? No! No baby or mother are harmed at all, as the umbilical cord tissue used is normally discarded anyway.

 

Can the stem cells cause a tumour?

Research shows that mesenchymal stem cells we use, do not cause or exacerbate tumours. There are over 10 research studies that have been performed on MSCs to see if they have tumour forming capacity, and the answer throughout has been no. Based on this, umbilical cord MSCs do not cause or exacerbate a tumor/cancer.

 

What does the procedure cost?

Our supplier is the world’s largest stem cell provider, and has used its volume to keep pricing as low as possible.

 

100 billion exosomes with an added Vitamin IV is R65 000.

 

Is there research showing that stem cell therapy works?

 

Absolutely! The amount of published studies evaluating mesenchymal stem cells and exosomes for human use exceeds 30,000 results. On clinicaltrials.gov, the amount of studies evaluating mesenchymal stem cells and exosomes exceeds 2,000.

 

Where does Healthspan Medical get its cells from?

Our Stem cells and exosomes are obtained from umbilical cord tissue/blood that has been donated by a consenting mother undergoing a c-section procedure. There is no harm to baby or mother.

 

What kind of testing is performed on the cells for safety?

Quality control on our stem cell's biologics exceeds that required by the USA FDA for safety. Along with the extensive donor questionnaire, disease testing of the tissue looks for HIV, Hepatitis, Syphilis, West Nile Virus, Chagas, Zika and more. The sterility testing looks for bacteria, virus, fungus and endotoxin. Only if all tests are passed are the stem cells and exosomes allowed to be used.

 

How long before I see benefits?

This will vary between patients. Most individuals with musculoskeletal pain will start to realise benefits within 2 to 4 weeks. It may be sooner or longer though. For those with a systemic issue, Autism, autoimmune, kidney failure, it may take 6-12 weeks to see results. Neurologic issues such as stroke, CPI, spinal cord injury may take 6 months to see improvements.

 

What are the risks of treatment?

Our exosomes have been used for over a decade of performing over 25,000 stem cell procedures worldwide. The quality control employed during the stem cell production is second to none, and the side effects we see are usually mild and temporary.

 

They may include itching, dizziness, lightheadedness, low grade fever, chills, nausea. These are typically temporary. If a patient has an allergic reaction to the multivitamin or a preservative, we have the medications to resolve it quickly. While we have rarely seen an infection, it is possible for it to occur as with anytime a medical procedure is performed.

 

What is an exosome?

Exosomes are lipid bound vesicles (acellular) produced by cells which contain a plethora of growth factors, cytokines, mRNA and

other proteins.

 

They are exceptionally helpful in cell to cell communication, and very effective for reducing inflammation when they become ingested by their recipient cell. They act as shuttles to send nucleic acids and proteins to other cells, in this way, allowing cell-to-cell communication and transporting molecules among both close and distant cells. In general, these released proteins are important regulators of intracellular information.

 

Exosomes could be the mediators of many stem cell- associated therapeutic activities. We have seen them to be “faster acting” than stem cells.

 

How do stem cells work in one’s body?

Stem cells and exosomes act in the body through several mechanisms. They do NOT become part of a patient’s DNA, which means they do not engraft into the person’s existing cells. The predominant method of action is thought to be through paracrine mechanisms, which means “cell to cell” interaction.

 

They act through:

1. Angiogenesis – provokes formation of new blood vessels.

2. Reduce inflammation –Cerebral Palsy is associated with significant acute and chronic inflammation, and the regenerative biologics reduce it nicely.

3.Immune system modulation – the stem cells and exosomes modulate the immune system very differently than steroids. Instead of blanketly suppressing the immune system, the regenerative biologics tamp down the harmful processes while amping up the beneficial ones. This includes ramping up production of several helpful growth factors and cytokines, while tamping down harmful ones.

4. Cellular signalling – the biologics are able to perform “cell to cell” communication. This promotes recipient cells to proliferate their growth factor production, protein production and regenerate tissues that are damaged.

5. Prevent cell death – most cells have a timed death, where they are only allowed to live a certain length of time. This is called apoptosis. The regenerative biologics allow normally functioning cells to live longer, and spare them from the pre-programmed death.

6. Preventing scar tissue – Scar tissue resulting from Cerebral Palsy is known to occur. Once that scar tissue forms, it becomes non-functional. Stem Cells and exosomes are great at preventing scar tissue (anti-fibrosis).

 

Are “hypoxic” stem cells better than those produced under normal oxygen conditions?

We get this question a lot. The answer is, maybe. The only data to show that hypoxic stem cells live longer and proliferate better than those produced under normal oxygen conditions is from the lab. Not in animals or humans, just from petri dish studies. From our perspective, this isn’t good enough. Our stem cell biologics and treatment protocols are based on actual evidence published in peer-reviewed journals. The results are fantastic, and they mirror those seen in high level research publications.

 

Are expanded stem cells (cultured) less effective than non-cultured ones? It depends. First of all, in the USA stem cells are not allowed to be expanded per regulations. Internationally, it’s allowed. If mesenchymal stem cells are expanded under GMP conditions, they are pure, potent and highly effective.

 

There is no evidence that non-cultured stem cells are more active than cultured. Unless the cells are “over-cultured”. If the cells are expanded past the 6th passage, the incidence of senescence (non-functional) stem cells starts to increase dramatically.

So it’s important for a lab to minimise the amount of passages.

 

The stem cell’s labs we use are very careful to minimise passages. We don’t allow cells past the 4th passage. So they are very powerful!