Cytopeutics-Pioneering Stem Cell Treatment & Research

Frequently Asked Questions

Question: What are stem cells?

Stem cells are cells capable of replicating itself or turning into specialized cells. One particular multipotent adult stem cell is known as the Mesenchymal Stem Cell or MSC. MSC gives rise to muscle cells including heart muscle, skeletal muscle and even the smooth muscle that wraps around our blood vessels and intestines. MSC also gives rise to cartilage – the ‘soft bone’ that sits on articular surfaces and joints that provide lubrication and mobility, and bone. Recent evidence also found that MSC can give rise to neurons or nerve cells, islet cells similar to the cells lost in diabetes and mesangial cells which are part of the kidney complex. Therefore MSC potentially have the ability to treat diseases and injuries involving these organs. Furthermore MSC is capable of tuning down the immune system which potentially be used for treatment of lupus, rheumatoid arthritis, multiple sclerosis and motor neuron disorders.

Question: Where are MSC found in the adults?

MSC are found in all children and adults, mainly in the bone marrow, umbilical cord blood and fat. MSC are very rare in the peripheral blood. Adult stem cells must not be confused with embryonic stem cells obtained from the unborn fetus which is unethical, known to be tumorigenic and banned in many countries, including Malaysia.

Question: Which is a better source of MSC?

Bone marrow is currently known to be the purer, richer and safer source of multipotent adult stem cell, MSC. In order to get the MSC as pure and unadulterated as possible it is best to harvest from the bone marrow, which is regarded as the “stem cell niche”. Mesenchymal stem cells (MSC) are very rare in the peripheral blood. Some doctors have tried to stimulate the stem cells into the peripheral blood, however the usage of stimulant / growth factor led to higher rates of coronary stent restenosis (blockage of the coronary stent) in patient with heart diseases. And this growth factor mainly stimulates only hematopoietic stem cells (HSC) that are committed to become only blood cells.

Question: How are MSC collected?

MSC are collected from patient’s own bone marrow via Bone Marrow Aspiration (BMA) by a qualified physician. BMA is a common procedure undertaken by hematologists or qualified physicians in which a small amount of bone marrow is aspirated from patient’s pelvic bone, normally the posterior iliac crest. It is a simple, convenient, safe and quick procedure where the whole process usually requires less than 20 minutes and it can be done under local anesthesia.

Question: Is there a need to expand or culture MSC?

MSC are found in all children and adults and perform their tasks daily to repair all parts of the body damaged through wear and tear. This repair is minimal and limited due to the small numbers of MSC in our body. Certainly there are not enough MSC in the body to mount a major rescue or salvage operation should there be overwhelming injury such as stroke or heart attack. Furthermore they dwindle with age and may be damaged particularly by smoking and radiation. It is important to expand these cells by a million fold so that they can be transplanted back into the patient’s body to boost the stem cell numbers and chances of self-repair and regeneration.

Question: Is there a need to store your own bone marrow MSC for future treatment purposes?

Regardless of age MCS can be harvested from patient’s bone marrow at any point of time. Scientists at Cytopeutics are able to isolate and expand MSC for treatment purposes. Therefore storage may not be necessary.

Question: Why is bone marrow aspiration a preferred MSC collection method compared to peripheral blood apheresis?

	BONE MARROW ASPIRATION	PERIPHERAL BLOOD APHERESIS
CONVENIENCE	Immediate (important for acute conditions such as stroke or spinal cord injury)	Needs daily stimulant / growth factor injection for consecutively 5 days (considerable delay, inconvenient and also uncomfortable)
CONSISTENCY	Always obtain mesenchymal stem cell (MSC)	Always obtain hematopoietic stem cell (HSC) and hardly MSC
COMFORT	Some pulling sensation	Dizziness, cramps, tingling of the nose, lips or fingers
EASE	20 mins	4 hours
EVIDENCE	Bone marrow MSC tested and promising for treatment of heart, brain, joint, bone and other diseases	HSC proven only for treatment of blood disorders eg. leukaemia and lymphoma
SAFETY	Safe for stroke and heart disease patients	Heart disease and heart failure patients may not tolerate
VOLUME	20-40 mL	2 - 3 Litres

Question: How does bone marrow MSC therapy work?

After obtaining MSC from bone marrow, they are expanded to sufficient numbers in million folds within 4-5 weeks. The cells are then injected back into the body to repair or replace any cell damage in the specific diseased organ or site of injury. Sometimes the bone marrow stem cells are injected with growth factors to allow the cells to home in to the site of action and/or to induce differentiation once they reach their destination.

Question: How is bone marrow MSC processed?

MSC is derived from your own bone marrow. Your cells will be processed in a professional lab equipped with state-of-the-art Class 100 (ISO Class 5) cleanroom for quality testing and separated from other less important cells found in the bone marrow. After separation the stem cells are cultured and expanded over 4-5 weeks until it has reached the desired number of cells. The cells are then frozen at temperature of -180°C so that they may be safely transported to your hospital for transplantation. At this temperature MSC are viable and there is very minimal risk of bacterial and fungal contaminations.

Question: Are there any side effects with MSC therapy?

Because MSC is derived solely from your own body, there is little fear of reaction or rejection by your body with this treatment. All steps are also being taken to ensure the cells are not contaminated or infected during cell processing and transportation.

Question: Why choose autologus (self-derived) adult bone marrow stem cell and not allogeneic (donor) stem cell treatment?

RISK OF VIRAL TRANSMISSION	Some viruses remain latent for up to 10 years. Many new viral diseases being discovered were not routinely tested during blood donation.
RISK OF CARCINOGENICITY	Many cancers have familial of genetic link. Therefore there is potential risk of genetic transfer by live nucleated cells. Stem cell has large nucleus. A young man may donate his stem cells now and develop cancer 20 years later.
RISK OF GENETIC ABNORMALITY	Few centers also routinely screen for genetic abnormalities which may manifest later in life.
ETHICAL CONCERN WITH DONOR	Was stem cell donation voluntary or was patient coerced? Did donors know their cells are used for research or treatment of other patients?
LAW VIOLATION	No money or inducement can be given to donor. Donated cell / tissue cannot be purchased or sold to unrelated recipient in accordance to the tissue and organ transplantation act of Malaysia.
QUALITY	Cells that has been stored for a long time – is it safe? Do we know what the expiry date is? How many passages of cell multiplication that is safe and effective for treatment?
COMPATIBILITY	How do we know if the cells are compatible with recipient? It is not as simple as blood typing test ABO. Until now, there is no standard protocol to check on MSC compatibility. Recent data suggest that allogeneic can be immunogenic mediated via MHC II.
LACK OF EVIDENCE	Scarce clinical data on safety and efficacy unlike autologous MSC.

Question: Why choose autologous stem cell culturing and treatment with Cytopeutics?

Cytopeutics has a team of dedicated and renowned stem cell experts from reputable local and international institutions and hospitals with more than 15 years of experience in stem cell research and development. The scientists are able to cultivate multiple millions of cells for single injection within 4-5 weeks and provide a Needle-to-Needle™ service to doctors. Apart from comprehensive support to doctors, client support personnel also provides full patient information and consent, patient counseling and complete patient follow up for up to a year. All treatments are evidence-based and quality assured for sterility, viability, purity of cells provided. Only animal-free culture medium is used for culture and as far as possible, induction factors are patient derived or certified as clinical grade safe for use. The source of cells is also wholly traceable in accordance to principles of Good Manufacturing Practice (GMP) and are not purchased or sold to unrelated recipients in accordance to the tissue and organ transplantation act of Malaysia. So far in Malaysia, pilot clinical treatments for patients with end-stage intractable heart failure and patients with severe disabling osteoarthritis have been completed with highly successful pilot results. Pilot treatment programmes are still ongoing for massive myocardial infarction, refractory angina, peripheral artery disease and ischemic foot ulcers, rheumatoid and other inflammatory arthritis, stroke, spinal cord injury and degenerative intervertebral disc disease. None of the patients so far have suffered any adverse event or complication as a direct consequence of stem cell treatment, with 90% reporting significant functional and symptomatic improvement.

Question: How does stem cell therapy work for stroke patient?

MSC may improve neurological functions by angiogenesis (regenerate blood vessels to restore blood supply) and neurogenesis (regenerate new nerve cells) while reducing inflammation and scar tissue. There have been numerous studies in the laboratory showing the benefits of stem cell in treating stroke. If you have stroke of no longer than three months, you may be eligible for Neuroncell^TM treatment (autologous bone marrow MSC). However, you should consult your regular doctor, neurologist or neurosurgeon to determine your eligibility criteria.

Question: My doctor says I have a cartilage defect caused by osteoarthritis. What does this mean?

Cartilage is the smooth, slippery, fibrous connective tissue that acts as a protective cushion between bones. Arthritis develops as the cartilage begins to deteriorate or is lost. As the articular cartilage is lost, the joint space between the bones narrows. This is an early symptom of osteoarthritis of the knee and is easily seen on X-rays. As the disease progresses, the cartilage thins, becoming grooved and fragmented. The surrounding bones react by becoming thicker. They start to grow outward and form spurs. The synovium (a membrane that produces a thick fluid that helps nourish the cartilage and keep it slippery) becomes inflamed and thickened. It may produce extra fluid, often known as "water on the knee," that causes additional swelling. Over a period of years, the joint slowly changes. In severe cases, when the articular cartilage is gone, the thickened bone ends rub against each other and wear away. This results in a deformity of the joint. Normal activity becomes painful and difficult.

Osteoarthritis can be a primary degenerative process, result from childhood hip disorders, or as secondary to adult injury, infection, endocrine/metabolic disorders or bone dysplasia.

Arthritis is the most common chronic musculoskeletal disorder, affecting nearly 23 million patients or 9% of the U.S. population, with osteoarthritis (OA) comprising about 70% of that patient population. Arthritis is the leading age-related medical condition among women and ranks as the second most common such condition among men over 45 years of age. As an age-related condition, about 20% of elderly patients suffer from OA and a significant portion of them are afflicted seriously enough to be considered disabled. Other causes are obesity, excessive use of joint and stresses, trauma, high impact injuries, infection and inflammation. Hip and knee osteoarthritis are the two most common forms of joint cartilage degeneration although the hands and fingers are also commonly affected.

Question: My doctor says I have or will develop an ulcer because of my legs’ poor blood supply. What does this mean?

Your arms and legs are supplied by long blood vessels which may be blocked as a result of smoking, diabetes, and high cholesterol. This is known as Peripheral Artery Disease or PAD. The pathological process is similar to that of a patient with heart attack and stroke therefore it is common for patients to also have some of these other conditions. As the blood supply becomes interrupted, patients normally complain that their calves are painful or cramp during walking. In severe situations, the legs lose all sensation of pain such that small ulcers and cuts go unnoticed. Because the skin is also lacking in blood supply, healing of the ulcer is very slow or not possible. As a result, the ulcer gets bigger and sometimes infected. In the worst situations when the infection has caused gangrene and septicaemia is imminent it becomes necessary to undergo a limb or digit amputation.

There are 1.2 million patients in Malaysia with diabetes who attend the government clinics. 6% of these patients develop foot ulcers annually. The incidence of major amputation is between 1-5 cases per 1000 people with diabetes. These are the patients with the most severe PAD and ulcers and usually have exhausted all medical and surgical options. They are the same group of patients for whom novel stem cell treatment such as Dermacell brings new promise and optimism.

Question: Can I avoid a bone marrow biopsy?

The bone marrow is currently the best source of stem cells. Stem cells are very rare cells normally tucked away in a very protected and inert environment. There are not enough of these cells in the blood stream. Some doctors have tried to stimulate the stem cells into the blood stream but most scientists and clinicians still find the number of cells obtained to be insufficient. Stem cells also start transforming once they enter the blood stream and come in contact with other cells. Therefore in order to get the stem cells as pure and unadulterated as possible it is best to harvest from the bone marrow.

Question: Is it safe in pregnancy?

It has not been tested in pregnancy. If you become pregnant during cell processing or after stem cell transplantation you must notify your doctor IMMEDIATELY.

Question: What side-effects have been reported with stem cell treatment?

The stem cell to be transplanted is accepted by experts as safe because it comes from your own body. In over 10 years of follow-up of patients who had received stem cell treatment derived from their own body, there has been no reported cases of cancer or infection related to the treatment. Every step is being taken to ensure the sterility of your stem cells. You will therefore be tested beforehand for any infectious diseases. These include bacteria, fungal, HIV, CMV, syphilis, HTLV, hepatitis B and C. Then your cells will be tested again in the lab before processing, at the end of processing and at the time of transplantation.

There are small risks associated with Bone marrow aspiration and sedation/anaesthesia. You may wish to discuss the risk with your Hematologist and anaesthetist respectively to find out more.