Tag Archives: Clinical trial

Clinical Trials For Heart Failure

What’s Heart Failure?

Heart failure is an intricate clinical condition of symptoms and signs that suggest malfunction of the heart. This is often caused by structural and or functional defects of the heart. A good number of patients have heart failures as a result of left ventricular systolic dysfunction (LVSD).

“More often than not, LVSD is associated with reduced left ventricular blood ejection fraction. Some patients have heart failure as a result of a preserved ejection fraction (HFPEF). Whereas the most popular cause of heart failure in the United States (US) is coronary artery disease, many patients have had a myocardial infarction,” Owan TE, Hodge D.O., Herges R.M, et al. (2006).

Heart failure and or related diseases often increase steadily with age, a typical age at first diagnosis being at 76 years. Prevalence of heart failure is even expected to rise in the near future as a result of an increased ageing population. Improved survival of people with heart disease and more effective treatments of the same are more reasons for such increased prevalence.

“Heart failure has a poor prognosis: 30–40% of persons diagnosed with the condition die within a year, after which the mortality rate is less than 10% for every succeeding year. However, there has been better prognosis in the past 10 years. The 6-month mortality rate further decreased from 26% in 1995 to 14% in 2005 and even further now,” Petersen S, Rayner M, and Wolstenholme J. (2002).

“Heart failure accounts for over a million inpatient bed-days 2% of all NHS inpatient bed-days in the US and 5% of all emergency medical admissions to hospital. The admissions because of the heart condition are even projected to rise by 50% over the next two decades, largely as a result of the ageing population,” Hobbs FD, Roalfe AK, and Davis R.C., et al. (2007).

This article provides acceptable and standard practices on adults with heart failures, especially those with chronic heart failures. Such trials entail diagnosis, treatment, and rehabilitation.

Heart Failure

Clinical Trials For Heart Failure

Clinical trials as well as therapeutic care should take into account the patients’ needs and preferences. A patient with acute heart failure for instance should be able to make or rather should be given an opportunity to make an informed decision about his/her therapeutic care together with the healthcare professionals.

If the patient does not have the ability to make reliable decision about his/her the trials and or therapeutic care, the healthcare professional should follow established guidelines set by the Department of Health on consent and the professional code of practice as set out in the Mental Capacity Act.

Also important is good communication between the patient and the professional. These may be in different forms but a recommended practice involves a written document that suits the patient’s unique clinic diagnosis and can also act as evidence. Clinical trials and therapeutic care given and information communicated to the patients should be appropriate to the latter’s medical history and culture.

Such information should be accessible to people with special needs such as physical, sensory, learning disabilities, and or to those who neither speak nor read English. Family members, guardians and or care-takers should also have an opportunity to contribute in the decisions about the trials and care.

“During clinical examinations, it is important to refer patients with supposed heart failures and or previous myocardial infarction (MI) urgently to have transthoracic Doppler 2D echocardiography and specialist assessment within 2 weeks,” Owan TE, Hodge D.O., Herges R.M, et al. (2006).

“Clinical trials on treatment should measure serum natriuretic peptides (B-type natriuretic peptide [BNP] or N-terminal pro-B type natriuretic peptide [NTproBNP]) in patients with suspected heart failure without previous MI. Because very high levels of serum natriuretic peptides carry a poor prognosis, refer patients with suspected heart failure and a BNP level above 400 pg/ml (116 pmol/litre) or an NTproBNP level above 2000 pg/ml (236 pmol/litre) urgently, to have the 2D echocardiography and assessment within 2 weeks,” Owan TE, Hodge D.O., Herges R.M, et al. (2006).

Heart Failure

Trials on treatment involve offering both angiotensin-converting enzyme (ACE) inhibitors and beta-blockers licensed for heart failure to all patients with heart failure due to left ventricular systolic dysfunction. It is also advisable to use clinical judgments when deciding which drug to use first.

Offer only beta-blockers licensed for heart failure to all patients with the heart condition due to left ventricular systolic dysfunction, including: adults and those patients with other vascular diseases, erectile dysfunction, diabetes mellitus, interstitial pulmonary disease, and or chronic obstructive pulmonary disease (COPD) without reversibility.

Professionals are also advised to seek specialist guidance to offer one of the following alternatives if the patient fails to respond to treatment despite optimum therapy with an ACE inhibitor and a beta-blocker. They may include: an aldosterone antagonist licensed to handle heart failure patients and an angiotensin II receptor antagonist (ARB) licensed for heart failure.

Clinical trials about rehabilitation should involve a supervised exercise-based rehabilitation program designed for patients with heart failure in groups. While at it, it is advisable to ensure the patient is stable and does not have a condition or device that would immaturely conclude the rehabilitation program.

During the program, you could also include a psychological and or educational component. The program may be incorporated within an existing exercise-based or other cardiac rehabilitation program.

“It should be noted patients with chronic heart failure require monitoring. This monitoring should include; a clinical assessment of functional capacity, fluid status, cardiac rhythm, nutritional status, cognitive status and a review of medication; including need for changes and possible side effects, serum urea, electrolytes, and creatinine. Also, when a patient is admitted to hospital because of heart failure, the professional should seek advice on their management plan from a specialist in heart failure,” Petersen S, Rayner M, and Wolstenholme J. (2002).

Lastly, patients with this kind of heart condition should generally be discharged from hospital only when their clinical condition is stable and the management plan is optimized. The timing should take into account patient and career wishes, and the level of community care and support.

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Clinical Trials For Heart Failure



Hematopoietic Cells to Treat TBI

Fetal Neural and Liver-Derived Hematopoietic Cells to Treat TBI

Hematopoietic cellsThe stem cells have been in the media for all the good reasons, scientists have been involved in research and trials on the viability of stem cells to be used in treatment of various conditions. The stem cells transplant has been seen as a potential therapeutic approach in treatment of traumatic brain injury as it helps in replacing the cells and tissues that are damaged as a result of a traumatic brain injury. Various types of stem cells such as the liver derived haemopoietic cells, embryonic rodent, immortalized progenitor cells and human stem cells and bone marrow-derived cells have been successfully transplanted in experimental models of traumatic brain injury resulting in reduced neurobehavioral deficits and attenuation of histological damage. However, till now there is still scarcity of literature on this issue and so it is rather unclear whether the stem cells can be transplanted and help in treatment of traumatic brain injury. the various ways through which the stem cells can be used in treating of traumatic brain injury include; cell replacement, trophic support, or manipulation of the local environment to stimulate endogenous regeneration but there is still a lot to be done to avail reliable information on this subject especially on the use of fetal neural stem cells which has been clouded with lots of controversy. there ought to be a sound understanding of the interaction between the recipient and the transplanted stem cells, the mechanism with which the stem cells work to restore the damaged cells ought to be understood especially how the immature fetal neural derived stem cells differentiate into mature neurons and help in treatment of traumatic brain injury, this can be achieved by further research on this issue.

Restorative approach to TBI treatment

In the past years, the approach toward the treatment of traumatic brain injury (TBI) has changed and taken a more restorative approach aiming at replacing and repairing the damaged tissues, cells and neurons damaged as a result of TBI. It is opined that the stem cell transplant is the best method for TBI treatment since the brain has a limited capacity to renew itself. The effectiveness of cell transplant in treating TBI has been seen in earlier experiments that involved transplantation of fetal neural tissues with or without nerve growth factor (NGF). In spite the effectiveness that was seen with the transplantation of fetal neural cells, a lot of controversy got sparked especially in concern of its practicality and ethics of its application.

On the other hand NT2N cells showed promise in graft survival, NGF gene therapy was also found to improve the cognitive deficits as a result of cortical contusion injury (CCI) in rodents. In most researches both rodent and human embryonic stem cells have shown encouraging results in survival, integration and attenuation of post-traumatic sequellae. The stem cells are flexible in treatment of disease as they possess the rare ability to differentiate into other cells and tissues hence can be used to replace the damaged cells in TBI. Particularly, the neural stem cells have the capacity to divide unlimitedly and differentiate into neurons as well as glial cells.

In a research done by Mahasweta Das, Subhra Mohapatra and Shyam S Mohapatra, It was found that mouse embryonic stem cells transplanted with or without a fibronectin scaffold following CCI improved behavioral symptoms . Xenotransplanted human neural stem cells have also been observed to survive in injured rodent brains and to express astrocytic and neuronal antigens. The transplanted cells migrated to the hippocampus, corpus callosum and ipsilateral sub-ependymal zone and reduced the number of degenerating neurons.

Hematopoietic or mesenchymal are advantageous

HematopoieticOf these stem cell types the bone marrow derived stem cells; hematopoietic and mesenchymal stem cells have been found to be advantageous when used as they can be harvested from the same patient and be transplanted in the brain of the same TBI patient hence limit the chances of donor unavailability or immune rejection. These cells have successfully been transplanted into injured rats by different routes where they express neural and glial cell markers and migrate to the subventricular zone, hippocampus and pericontusional areas showing neurogenesis and improved neurobehavioral outcome. The transplanted neural stem cells also modified to encode brain derived neurotrophic factor (BDNF) in rats after TBI and found significant improvement in graft survival, neurogenesis and behavioral outcome.

Another study in winster rats, that the functional improvement and colonization of bone marrow mesenchymal stem cells were observed after TBI and the recovery was found to be facilitated by granulocyte colony stimulating factor (G-CSF). Human fetal neural stem cells (hfNPCs) transplanted after CCI in rats increased angiogenesis and reduced astrogliosis. In these experiments it can be seen that stem cell transplant might have positive input in the treatment of TBI in humans. However, it is good to note that there are few trials that have been done on humans and so the use of fetal neural stem cell implantation in treatment of TBI should still be approached with caution until there would be enough wok to prove not only their safety but also their effectiveness.

Finally, for more information about bone marrow transplant and stem cell transplantation, visit www.awaremednetwork.com Dr. Dalal Akoury has garnered years of experience in integrative medicine and will be able to help. Feel free to visit http://www.integrativeaddiction2015.com and know more about the upcoming Integrative Addiction Conference 2015. The conference will equip you with unique approaches of telling symptoms of addiction and how to help patients battling addiction.

Fetal Neural and Liver-Derived Hematopoietic Cells to Treat TBI



Why are Stem Cells Important?

What are stem cells, and why are they important?

Stem cellStem cells are very special, powerful cells found in both humans and also in other animals. Stem cells are the precursors of all cells in the human body. What makes stem cells special is that they are regenerative and malleable. They have the ability to replicate themselves and to repair and replace other tissues in the human body. Some tissues, like skin, need constant renewal, which could not take place without skin stem cells. Other stem cells repair damage to the body’s tissues, for example, rebuilding damaged or degenerating muscle tissue. New research also indicates that stem cell malfunction or damage may be responsible for certain cancers and even muscular-degeneration diseases like Muscular Dystrophy.

Stem cells differ from other kinds of cells in the body. All stem cells have three general features that make them different from other body cells. These features are: they are capable of dividing and renewing themselves for long periods. They are unspecialized and they can give rise to specialized cell types. Stem cells are capable of dividing and renewing themselves for long periods. Unlike muscle cells, blood cells, or nerve cells which do not normally replicate themselves, stem cells may replicate many times, or proliferate.

The stem cells have a unique ability to divide and become more specialized cells forming cells like bone, blood, or muscle. It is this ability that makes them attractive agents in many areas of medicine. They can therefore be used to fight very many diseases in the regenerative medicine. Another advantage of stem cell therapy treatments is that autologous stem cell transport is made possible. This means that a person may be treated by doctors harvesting the stem cells from the patient and having the stem cells reimplanted into the same patient after finding out what was lacking in the patient. This reduces risks of infection as well as rejection which are helpful to the patient.

Importance of stem cells

the stem cells are very important cells in the body and have been since targeted for treatment of degenerative diseases. They have been called the center pieces of regenerative medicine. Medicine that involves growing new cells, tissues and organs to replace or repair those damaged by injury, disease or aging. there ability to proliferate into other cells of the body like the bone and muscle tissues have made them a priority in treatment of various degenative diseases like aging and even osteoporosis among others. here is how stem cells work in treatment of various diseases.

Rejuvenation– the stem cells can be used in rejuvenation process. through rejuvenation the bodies healing ability is boosted. Typically, the body is programmed to naturally repair itself that is why after you get a cut you can stay without going to hospital but still get healed within a very short time. However there other crucial organs that when damaged do not easily get repaired. When the body’s cells cannot get differentiated to give rise to new healthy cells and heal the damaged cell then there is a problem. According to Mayo clinic the cells that were once thought of as terminally differentiated including the heart, lungs and nerves which are more specialized are able to remodel as they possess ability to self-renew. However researchers are still working to come up with strategies through which the ability of these cells to self-heal can be enhanced.

Stem cellReplacement– here the stem cells can be used to replace the damaged cells.in degenerative diseases like osteoporosis the damaged tissues can be replaced with fresh stem cells that will proliferate into more functional bone issues and relieve the system of the damaged tissues. the stem cells can be transplanted in autologous manner where the stem cells will be harvested in the adipose or the bone marrow and be used to replace the affected cells in organ. with autologues stem cell transplant the issue of donor is not a problem neither are there issues of rejection nor the need for immunosuppression .

Regeneration- Through regeneration the stem cells are delivered to diseased tissues or organs, where they will ultimately restore tissue and organ function. This can be done through cell-based therapy or by using cell products, such as growth factors. Bone marrow transplants are an example of regeneration. Regeneration aims to awaken cells that are not functional or have malfunctions. With stem cell therapy there is hope for affordable healthcare solutions that heal the body whole without life threatening side effects.

Stem cells are a cutting edge

Stem cells are capable of self-renewing giving rise to several copies of themselves. They also have the capability of shifting shape and changing type, therefore they can be used to form the cells that are damaged and restore the functions of the damaged tissues. The stem cells can be used to replace the cells that have malfunctioned due to structural damage. The amazing part of the stem cell differentiation is that when a stem cell divides both the daughter cell and the parent stem cells have the potential to differentiate into different cells or to still remain as stem cells. Owing to this ability of stem cells to differentiate into more specialized cells, they can rebuild lost blood vessels, reverse scarring, regenerate damaged nerves, and bring back the healthy you.


Stem cell therapy has a lot to offer to patients, Visit us at AWAREmed Health and Wellness Resource Centre at Myrtle Beach, South Carolina. Dr. Dalal Akoury (MD) an expert in integrative and regenerative medicine will be able to help.

What are stem cells, and why are they important?



Treating Diabetes With Stem Cells

Stem Cell Therapy for Diabetes

DiabetesDiabetes is a serious disease that has continued to debilitate the human race. This disease comes in two forms namely the diabetes type 1 which is also known as juvenile and the type 2 diabetes which is also known as adult diabetes. The type 1 diabetes is an autoimmune disorder which occurs when the immune system mistakenly attacks and kills the beta cells of the pancreas. When this happens the release of insulin in the body will be interfered with adversely. Consequently, sugar builds up in the blood instead of being used as energy. About five to 10 per cent of people with diabetes have type 1 diabetes. Type 1 diabetes generally develops in childhood or adolescence, but can also develop in adulthood. Type 1 diabetes is always treated with insulin. However some dietary approaches can be used to help in keeping the sugar level right.

Diabetes is one of the top ten leading causes of death worldwide according to a recent WHO report; in 2012 the global prevalence of diabetes was estimated to be more than 10% among adults. The most prevalent type of diabetes is the type 2 and it is rampant in adult population. Diabetic patients develop hypertension and cardiovascular diseases, which account for high rates of morbidity and mortality among adult patients. In the past treatment of diabetes has been marred by different factors, oral medications that were the major form of treatment are not as effective as after sometime the patient may develop insulin dependence. Oral insulin medication is also not so effective since exogenous insulin cannot provide the tight glycemic control exerted by the pancreas-derived insulin secretion. Researchers consequently have been prompted to come up with better ways of addressing this menace. Stem cell therapy is the new effective way that is hoped to save the human race. It works by replacing the damaged cells and normalizing the blood sugar level.

Autologous stem cell transplant for treatment of diabetes

The stem cells are very important owing to their crucial functions in the body. These cells are present in the bone marrow and in the adipose tissues. Owing to their ability to form other cells and tissues, they can be harvested from either the bone marrows or the adipose tissues and be used to heal or replace cells in the affected places. When the harvest of the stem cells is done from the patient’s own body and the used within his body then it is called autologous stem cells transplant. Autologous stem cell transplant is safer since the cells are from the body and therefore there is no risk of them getting rejected neither to induce unpleasant allergic reaction nor require need for immunotherapy. The autologous stem cell therapy can be used to replace the affected cells and help restore proper functioning.

In autologous stem cell transplants, the doctors use peripheral blood stem cell transplantation. With peripheral blood stem cell transplantation, the stem cells are taken from blood. The growth factor G-CSF may be used to stimulate the growth of new stem cells so they spill over into the blood. G-CSF is a protein that is produced naturally in the body. The blood is removed from a vein and passed through a machine that separates the stem cells. The machine then returns the remaining blood through a needle in the person’s arm or through a central venous catheter. This way of collecting stem cells is called apheresis

Using mesenchymal cells yields best results

DiabetesBefore the use of autologous stem cell transplant, the islet transplantation was majorly used in cell based therapy for diabetes treatment. This method however successfully used in the past has its own disadvantages. Its major pitfalls included the following; limited donors, graft rejection, the need for continued immune suppression and exhaustion of the donor cell pool. To help fill these pitfalls that made this treatment unpleasurable, researchers targeted the stem cell therapy as a better alternative and they were not wrong, it has been noted that the stem cell therapy works better for diabetic patients who fail to control hyperglycemia even with insulin injection. This is because autologous cells are readily available and do not entail prolonged hospital stays or sustained immunotoxic therapy. Among autologous adult stem cells, mesenchymal stem cells therapy has been applied with varying degrees of success in both animal models and in clinical trials.

The cell based therapies had been introduced in treatment of diabetes for diabetes mellitus and it surely achieved success. It involved the use of islet transplantation. It was so successful especially in treatment of diabetes type 1 but it had some other failures that could not be overlooked and it’s these failures that are now addressed by the stem cell therapy. Stem cell therapy is a solution to some of the drawbacks of islet transplantation especially the shortage of donors. Autologous stem cell therapy allows for a person’s on organs to be used in the transplant.

The mesenchymal stem cells are used as they are able to proliferate and form new more effective cells replacing the damaged cells. They are mostly harvested in both the bone marrow and the adipose tissues where they are available in the highest amount. The mesenchymal stem cells help maintain the capacity of multilineage differentiation potential, both within and across lineage barriers. They are easy to cultivate and expand, and maintain pluripotentiality after prolonged culture conditions.

Diabetes is a killer disease; visit us at AWAREmed Health and Wellness Resource Centre at Myrtle Beach, South Carolina. Dr. Dalal Akoury (MD) an expert in integrative and regenerative medicine will be able to help.

Stem Cell Therapy for Diabetes



Stem Cell Therapy and Osteoarthritis of the Elbow

Stem Cell Therapy for Osteoarthritis of the Elbows

OsteoarthritisOsteoarthritis is a disease that many people are suffering from and is one of the diseases that are not very easy to treat. According to Mayo clinic, Osteoarthritis is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage on the ends of your bones wears down over time. Although osteoarthritis can damage any joint in your body, the disorder most commonly affects joints in your hands, knees, hips and spine. Osteoarthritis of the elbow is also common. This disease often begins gradually but worsens with time. However till now there is no conventional cure for osteoarthritis. even those medicines that are used to mitigate on the symptoms of osteoarthritis none of the conventional treatments addresses the damage that is caused on the joints neither is there any avenue in the mainstream medicine through which the cartilage erosion on the elbow joints, knee joint or any other joint can be done away with. most of the time a person who is suffering from osteoarthritis of any kind is told to stay active, maintain a healthy weight and use other available treatments to help mitigate on effects of the disease; reduce the joint pain and function.

Due to the absence of mainstream treatment for osteoarthritis, patients have been facing untold horror of a lifetime. This inconvenience and pain that osteoarthritis patients have been put through as a result of this vacuum in the medical field, researchers have been working on different issues to come up with the best treatment for this disease. Researchers have mostly centered on the need for tissue regeneration therapies as this will be the only viable approach to healing the eroded cartilage on the joints. The erosion of cartilage on the elbow joint is the major characteristic of osteoarthritis of the elbow.

The bone diseases have been a major problem in the field of medicine with osteoarthritis being the major culprit affecting about 27 million people in America. Some of the common risk factors include increasing age, obesity, previous joint injury, overuse of the joint, weak thigh muscles, and genetics. In the past patients of this disease had no hope of ever breaking its chains but with recent studies on mesenchymal stem cells, a lot are changing in relation to the way doctors treat bone diseases. Stem cells have been used for the treatment of osteogenesis imperfecta, hypophosphatasia, osteonecrosis of the femoral head, osteoporosis, rheumatoid arthritis and osteoarthritis of the elbow.

Today there are several hospitals that offer treatments to the joint diseases. Shoulders, knees, and hips joints are amongst the most common. However, there are other areas that can be treated with stem cell therapy are thumbs, toes and wrists. People who are active golfers, tennis or racquetball players, and avid bowlers may experience more pain from overuse of the elbow joint. Mild to moderate osteoarthritis is one of the main causes of a painful joint. This explains why most NFL players have gone for stem cell therapy to correct defects in their joint injuries.

Stem cell therapy for elbows may be an ideal nonsurgical alternative for those who suffer from elbow pain because of injury or pain related to osteoarthritis, or muscle sprains and strains. Traditional surgery for the elbows can be difficult because of the complexity of the joint, and it often requires a painful, lengthy rehabilitation process to restore the full range of motion. Before making the leap into a surgical procedure, you need to consider having a stem cell treatment as that may have better results.

Mesenchymal stem cells in joint disease and repair

OsteoathritisThe mesenchymal have been known for their unique abilities. They are able to form other body cells and tissues and so can be used to replace the worn out tissues at the joints. Apart from their ability to form new cell types that can replace the worn out cartilage, the mesenchymal stem cells have a potential for articular cartilage regeneration, however this favorable research is centered on surgical implant of the stem cells. Now doctors have found that for the treatment of generalized cartilage loss in osteoarthritis, an alternative delivery strategy would be more appropriate and that is injection therapy. The advantage of the injection therapy is that there will be no need for any surgery.

The adverse effects of osteoarthritis can never be overemphasized, those who have fallen victims know much of the nightmares it causes, and the pain that these patients have to endure can never be overlooked. The research surrounding an effective treatment for osteoarthritis has yet to find an approved pharmacological intervention, biologic therapy or procedure that prevents the progressive destruction of the osteoarthritis joint. Stem cell injections for osteoarthritis can help maintenance healthy tissues by acting as repair cells or to reduce inflammation. The injection of Mesenchymal stem cells has produced promising outcomes in preclinical models of joint disease. It is hoped that the use of stem cell therapy in treatment of osteoarthritis of the elbow will be of help to those already suffering from the disease.

Finally, degenerative diseases like osteoarthritis have debilitated many people. In spite of the fact that it has never been treated in the past, it is hoped that with stem cell therapy, osteoarthritis will be a treatable disease. Dr. Dalal Akoury (MD) is an expert in integrative medicine and a founder of AWAREmed Health and Wellness Center located at Myrtle Beach South Caroline. Visit her for more information on most lifestyle diseases.

Stem Cell Therapy for Osteoarthritis of the Elbows