Our FAQ page aims to answer some of the most common questions we are asked about our treatments and services. It also seeks to cover the basic differences between regenerative medicine therapies.
‘Specials’ are unlicensed medicines designed to meet individual patient’s clinical needs that a licensed medicine cannot meet, the UK law allows the manufacture and supply of unlicensed medicines subject to certain requirements. There are many clinical situations when the use of unlicensed medicines or ‘specials’ may be judged by the doctor or prescriber to be in the best interest of the patient, for example the patient may have exhausted every other available licenced treatment options with no satisfactory clinical outcome.
In terms of stem cell/regenerative medicine the patient may not be suitable for surgery and is no longer responding to steroid injections. In this case there is an established medical need and clinician may prescribe a stem cell treatment. This is then prescribed as an unlicensed medicine that has been produced under special manufacturing licences.
Manufacturers are not allowed to advertise or promote individual ‘Special’ products, because under the Medicines Act it is only possible to advertise licensed medicines. When selecting a ‘Specials’ manufacturer, it is important to make sure they hold an appropriate Manufacturer’s ‘Specials’ licence and they can provide certificates of analysis or only a certificate of conformity.
If your prescriber establishes a clear medical need for stem cell therapies and you are over the age of 18 and under the age of 75 (excluding pregnant women) you should be eligible for an initial health screening with their practitioner to establish any contraindications that may prevent treatment. If there are no contraindications you will be given a date for treatment.
Mesenchymal stem cells (MSCs) are located throughout the body and are the body’s natural healer. Stem cells used for medicinal purposes are thought to accelerate tissue repair, stimulate tissue regeneration, decrease inflammation and stimulate new blood vessel growth.
Stem cells are needed to live, as they continually renew every cell in our body. Stem cells have the clever ability to develop into many different types of cells. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specific function, such as cartilage, muscle or a red blood cell. Stem cells can be found in high concentrations in adipose tissue (fat) and in bone marrow.
Mesenchymal stem cells that reside in human tissue regenerate musculoskeletal tissues such as cartilage, tendons and ligaments.
To remain healthy joints depend on the availability and activity of stem cells. Stem cells can be aspirated with minimal discomfort from adipose tissue (fat). These cells can then be grown and expanded using a specialist facility, the multiplied cells can then be re-injected back into the patient directly to where they are experiencing pain, such as the knee or hip.
Stem cells are the body’s natural healer they act as potential mediators of anti-inflammatory and enhanced wound healing effects in orthopaedics. By administering more stem cells into a painful joint there is the potential to assist the self-healing process of the joint, slow down degeneration and control inflammation, which is the main cause of pain and discomfort.
Unfortunately, due to a global rise in unscrupulous companies taking advantage of individuals by offering untested, unregulated and deceptive stem cell treatments, patients are some times left confused by what is properly regulated. Thankfully there are very strict regulations and licensing in place in the UK. These are very much welcomed by LifePlus Stem Cells and other professional regulated stem cell providers as it prevents the undermining of legitimate new therapies such as ours. Stem Cell therapies are classed as an unlicensed medicines (‘specials’). Read more about licensing here.
- Anyone over the age of 18 and under the age of 75
- The patient is classed as ASA1 or ASA2 patient
- The health professional has reviewed the patient’s medical & behavioural
history and deem the patient fit for the procedure
- The patient has been through a physical examination deemed fit for the procedure
- Health professional has reviewed the patient’s blood results for markers
Autologous stem cells are the opposite of allogeneic stem cells, as the patient is both donor and receiver. Autologous stem cell therapy is when stem cells are harvested from the patient’s own body, and will be transplanted back to the patient for treatment of a variety of conditions such as knee arthritis or shoulder injuries.
Allogeneic treatments use cells from a donor, in this case human umbilical cord. Cells that remain in the human umbilical cord after birth supplies doctors with a rich source of Mesenchymal stem cells MSCs. All cells are obtained ethically from fully consenting donors after a scheduled C-section, utilising tissues that would usually be discarded.
Umbilical cord derived stem cells are newer and less mature than other cells, therefore the body’s immune system does not recognise them as foreign and the body does not reject these cells. Thousands of patients have been treated with umbilical cord stem cells without a single instance of rejection. MSC’s also proliferate more efficiently than “older” cells, such as those found in the bone marrow or fat and therefore, they are considered to be more potent.
Mesenchymal stem cells derived from umbilical cord tissue (UC‐MSCs) have immune‐modulatory and anti‐inflammatory properties, and have been safely used to treat a variety of conditions. The advantage of using human cord is that it’s rich in blood stem cells, similar to those found in bone marrow, they are highly versatile and can be used to treat many different orthopaedic and aesthetics conditions. MSCs derived from umbilical cords have been receiving increasing interest in the field of clinical orthopaedic regenerative medicine.
Adipose tissue is body fat which is primarily made up of fat cells known as adipocytes. Adipose tissue can be found in pockets of fat removed from the lower abdomen and inner thigh. Fat in these areas is an excellent source of stem cells, with higher stem cell concentrations than other areas of the body (American Society of Plastic Surgeons). Unlike the limited quantities of bone marrow derived stem cells “BMSCs” they are harvested. Stem cells derived from fat grow faster in the laboratory and tend to be more resilient which makes them ideal for growing in a lab.
Adipose fat stem cells are useful in treatments since they have the ability to home and undergo osteogenic, adipogenic, chondrogenic, and even neurogenic differentiation. Adipose stem cells are also immunoprivileged meaning they are tolerated without eliciting an inflammatory immune response and therefore have virtually no chance of rejection, preventing any risk to the patient. Adipose tissue is also a pain-free way to extract stem cells, as opposed to bone marrow aspiration which can be painful, can cause bruising and aching for a number of days.
“Homologous use” means that a human cellular or tissue product is used clinically in a manner that is essentially the same as the natural endogenous function that it performed. For stem cells to qualify as “homologous use” they must be used clinically to do what nature originally intended rather than a different job, for example taking cartilage cells to repair cartilage in an arthritic knee, therefore used for the same endogenous function. The same could be said for using heart cells to repair heart valves or fat cells from the abdomen to be used as a filler for the face.
Non-homologous use involves taking stem cells from adipose tissue or bone marrow and using them almost anywhere in the body to repair any type of cells regardless of their natural endogenous function. Non-homologous use offers a far wider range of treatment options and as a result falls under very strict regulations. All non -homologous adipose or bone marrow-derived stem cell therapies, including bedside centrifuge techniques and even PRP, must have the relevant HTA and MHRA licences to be legally offered as a regenerative medicine treatment.
Under the EU Tissues directive, all non-homologous stem cells therapies have to be licenced as a medicine under the Medicines and Healthcare products Regulatory Agency MHRA licence regulations along with a Human Tissue Authority (HTA) licence. LifePlus Stem Cells are the first to carry all necessary licences for non-homologous stem cell therapies for regenerative medicine.
Cells are cultured on plastic.
To amplify the cells:
Autologous 3-4 passages
Allogeneic around 10 passages
Are post amplification checks performed to confirm that the developed cell lines are indeed MSC’s and not altered?
Yes, our products have a certificate of analysis which not only certifies the products are infection free and produced with the appropriate HTA and MHRA licences, but also quantifies the product, which we believe is a first in the market.
We are referring to the viability and purity of the cells cultured. Our figures show we are producing to 80% pure stem cells regularly.
An authorised courier for regenerative frozen products is used to ensure safe delivery. Currently our service is not possible outside the UK.
Stem cells are activated by simply thawing them at room temperature and used within a specific time frame.