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Sickle Cell Anemia: Learn About SCD Symptoms and Treatment

By Uncategorized

Sickle cell anemia (SCD) facts

Sickle cell anemia (sickle cell disease) is a disorder of the blood caused by an inherited abnormal hemoglobin (the oxygen-carrying protein within the red blood cells). The abnormal hemoglobin causes distorted (sickled) red blood cells. The sickled red blood cells are fragile and prone to rupture. When the number of red blood cells decreases from rupture (hemolysis), anemia is the result. This condition is referred to as sickle cell anemia. The irregular sickled cells can also block blood vessels causing tissue and organ damage and pain.

Sickle cell anemia is one of the most common inherited blood anemias. The disease primarily affects Africans and African Americans. It is estimated that in the United States, some 90,000 to 100,000 Americans are afflicted with sickle cell anemia. Overall, current estimates are that one in 500 U.S. African American births is affected with sickle cell anemia.

Sickle cell anemia is inherited as an autosomal (meaning that the gene is not linked to a sex chromosome) recessive condition. This means that the gene can be passed on from a parent carrying it to male and female children. In order for sickle cell anemia to occur, a sickle cell gene must be inherited from both the mother and the father, so that the child has two sickle cell genes.

The inheritance of just one sickle gene is called sickle cell trait or the "carrier" state. Sickle cell trait does not cause sickle cell anemia. Persons with sickle cell trait usually do not have many symptoms of disease and have hospitalization rates and life expectancies identical to unaffected people. When two carriers of sickle cell trait mate, their offspring have a one in four chance of having sickle cell anemia. (In some parts of Africa, one in five persons is a carrier for sickle cell trait.)

Medically Reviewed by a Doctor on 5/21/2015

Sickle Cell Disease (Sickle Cell Anemia) - Experience Question: Please describe your experience with sickle cell disease (sickle cell anemia).

Sickle Cell Disease (Anemia) - Diagnosis Question: How was your sickle cell anemia diagnosed?

Sickle Cell Disease (Sickle Cell Anemia) - Symptoms Question: At what age did symptoms of sickle cell anemia first appear in someone you know? Please describe other symptoms.

Red blood cells are manufactured in the bone marrow. Their unique biconcave shape (think of squeezing a marshmallow between your fingers) increases their storage capacity for hemoglobin molecules that carry oxygen. They also make the cells pliable and soft so they can squeeze through the tiniest blood vessels in the body. In sickle disease, the red blood cells form an abnormal crescent shape that is rigid, causing the red blood cells to be damaged. The cells aren't malleable enough to get through tight spaces, and this can increase the risk of forming blood clots in the small capillaries of different organs causing the potential for organ damage.

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Sickle Cell Anemia: Learn About SCD Symptoms and Treatment

Sickle Cell Disease (Sickle Cell Anemia … – MedicineNet

By Uncategorized

What are the symptoms and treatments of sickle cell anemia?

Virtually all of the major symptoms of sickle cell anemia are the direct result of the abnormally shaped, sickled red blood cells blocking the flow of blood that circulates through the tissues of the body. The tissues with impaired circulation suffer damage from lack of oxygen. Damage to tissues and organs of the body can cause severe disability in patients with sickle cell anemia. The patients endure episodes of intermittent "crises" of variable frequency and severity, depending on the degree of organ involvement.

The major features and symptoms of sickle cell anemia include:

Some features of sickle cell anemia, such as fatigue, anemia, pain crises, and bone infarcts can occur at any age. Many features typically occur in certain age groups.

Sickle cell anemia usually first presents in the first year of life. Infants and younger children can suffer with fever, abdominal pain, pneumococcal bacterial infections, painful swellings of the hands and feet (dactylitis), and splenic sequestration. Adolescents and young adults more commonly develop leg ulcers, aseptic necrosis, and eye damage. Symptoms in adult typically are intermittent pain episodes due to injury of bone, muscle, or internal organs.

Affected infants do not develop symptoms in the first few months of life because the hemoglobin produced by the developing fetus (fetal hemoglobin) protects the red blood cells from sickling. This fetal hemoglobin is absent in the red blood cells that are produced after birth so that by 5 months of age, the sickling of the red blood cells is prominent and symptoms begin.

The treatment of sickle cell anemia is directed to the individual features of the illness present. In general treatment is directed at the management and prevention of the acute manifestations as well as therapies directed toward blocking the red blood cells from stacking together. There is no single remedy to reverse the anemia. It is, therefore, important that affected individuals and their family members have an optimal understanding of the illness and that communication with the doctors and medical personnel be maintained.

Fatigue is a common symptom in persons with sickle cell anemia. Sickle cell anemia causes a chronic form of anemia which can lead to fatigue. The sickled red blood cells are prone to breakage (hemolysis) which causes reduced red blood cell life span (the normal life span of a red blood cell is 120 days). These sickled red blood cells are easily detected with a microscope examination of a smear of blood on a glass slide.

Typically, the site of red blood cell production (bone marrow) works overtime to produce these cells rapidly, attempting to compensate for their destruction in the circulation. Occasionally, the bone marrow suddenly stops producing the red blood cells which causes a very severe form of anemia (aplastic crises). Aplastic crises can be promoted by infections that otherwise would seem less significant, including viruses of the stomach and bowels and the flu (influenza).

The anemia of sickle cell anemia tends to stabilize without specific treatments. The degree of anemia is defined by measurement of the blood hemoglobin level. Hemoglobin is the protein molecule in red blood cells which carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues to the lungs. Blood hemoglobin levels in persons with sickle cell anemia are generally between 6 to 8 gms/dl (normal levels are above 11 gms/dl). Occasionally, there can be a severe drop in hemoglobin requiring a blood transfusion to correct the anemia (such as in patients suffering splenic sequestration). Blood transfusion is usually reserved for those patients with other complications, including pneumonia, lung infarction, stroke, severe leg ulceration, or late pregnancy. (Among the risks of blood transfusion are hepatitis, infection, immune reaction, and injury to body tissues from iron overload.) Transfusions are also given to patients to prepare them for surgical procedures. Folic acid is given as a supplement. Sometimes a red blood cell exchange is performed. This process removes some of the sickle blood cells and replaces them with normal (non-sickle) blood cells. It is done when the sickle cell crisis is so sever that other forms of treatment are not helping.

Pain crises in persons with sickle cell anemia are intermittent painful episodes that are the result of inadequate blood supply to body tissues. The impaired circulation is caused by the blockage of various blood vessels from the sickling of red blood cells. The sickled red blood cells slow or completely impede the normal flow of blood through the tissues. This leads to excruciating pain, often requiring hospitalization and opiate medication for relief. The pain typically is throbbing and can change its location from one body area to another. Bones are frequently affected. Pain in the abdomen with tenderness is common and can mimic appendicitis. Fever frequently is associated with the pain crises.

A pain crisis can be promoted by preceding dehydration, infection, injury, cold exposure, emotional stress, or strenuous exercise. As a prevention measure, persons with sickle cell anemia should avoid extremes of heat and cold.

Pain crises require analgesia for pain and increased fluid intake. Dehydration must be prevented to avoid further injury to the tissues and intravenous fluids can be necessary. Along with the fluids clotrimazole and magnesium are often given. Other modalities, such as biofeedback, self-hypnosis, and/or electrical nerve stimulation may be helpful.

Hydroxyurea is a medication that is currently being used in adults and children with severe pain from sickle cell anemia. It is also considered for those with recurrent strokes and frequent transfusions. This drug acts by increasing the amount of fetal hemoglobin in the blood (this form of hemoglobin is resistant to sickling of the red blood cells). The response to hydroxyurea is variable and unpredictable from patient to patient. Hydroxyurea can be suppressive to the bone marrow.

Swelling and inflammation of the hands and/or feet is often an early sign of sickle cell anemia. The swelling involves entire fingers and/or toes and is called dactylitis. Dactylitis is caused by injury to the bones of the affected digits by repeated episodes of inadequate blood circulation. Dactylitis generally occurs in children with sickle cell anemia from age 6 months to 8 years.

Joint inflammation (arthritis) with pain, swelling, tenderness, and limited range of motion can accompany the dactylitis. Sometimes, not only the joints of the hands or feet are affected, but also a knee or an elbow.

The inflammation from dactylitis and arthritis can be reduced by anti-inflammation medications, such as ibuprofen and aspirin.

Lung infection (pneumonia) is extremely common in children with sickle cell anemia and is also the most common reason for hospitalization. Pneumonia can be slow to respond to antibiotics. The type of bacteria that is frequently the cause of pneumonia is called the pneumococcus. (This is, in part, due to the increased susceptibility to this particular bacteria when the spleen is poorly functioning.) Vaccination against pneumococcal infection is generally recommended.

Children with sickle cell anemia are also at risk for infection of the brain and spinal fluid (meningitis). Bacteria that are frequent causes of this infection include the Pneumococcus and Haemophilus bacteria.

Furthermore, children with sickle cell anemia are at risk for an unusual form of bone infection (osteomyelitis). The infection is typically from a bacteria called Salmonella.

Bacterial infections can be serious and even overwhelming for patients with sickle cell anemia. Early detection and antibiotic treatment are the keys to minimizing complications. Any child with sickle cell anemia must be evaluated by medical professionals when fever or other signs of infection (such as unexplained pain or cough) appear.

Over time, the spleen can become damaged and stop working, which increases the risk of developing various severe infections.

It has been demonstrated that the liver, and especially the spleen, are organs that are very active in removing sickled red blood cells from the circulation of persons with sickle cell anemia. This process can accelerate suddenly. Sudden pooling of blood in the spleen is referred to as splenic sequestration.

Splenic sequestration can cause very severe anemia and even result in death.

The spleen is commonly enlarged (splenomegaly) in younger children with sickle cell anemia. As the spleen is repeatedly injured by damage from impaired blood supply, it gradually shrinks with scarring. Impairment of the normal function of the spleen increases the tendency to become infected with bacteria.

Sudden pooling of blood in the spleen (splenic sequestration) can result in a very severe anemia and death. These patients can develop shock and lose consciousness. Transfusion of blood and fluids can be critical if this occurs.

Liver enlargement (hepatomegaly) occurs as it becomes congested with red blood cells as well. The liver is often firm and can become tender. Impaired liver function can result in yellowing of the eyes (jaundice). The gallbladder, which drains bile from the liver, can fill with gallstones. Inflammation of the gallbladder (cholecystitis) can cause nausea and vomiting and require its removal.

Aside from lung infection (pneumonia), the lungs of children with sickle cell anemia can also be injured by inadequate circulation of blood which causes areas of tissue death. This lung damage can be difficult to distinguish from pneumonia and is known as acute chest syndrome. These localized areas of lung tissue damage are referred to as pulmonary infarcts. Pulmonary infarcts often require a special x-ray test using a dye injected into the affected areas (angiogram) for diagnosis. Repeated pulmonary infarcts can lead to scarring of the lungs of children with sickle cell anemia by the time they reach adolescence.

The heart is frequently enlarged in children with sickle cell anemia. Rapid heart rates and murmurs are common. The heart muscle can also be injured by infarcts and iron depositing in the muscle as it leaks from the ruptured red blood cells. Over time, the heart muscle weakens and the heart pumps blood more and more poorly.

Injuries to the lungs or heart are treated according to the specific type of damage and the degree of impairment of organ function. Supplementary oxygen can be required. Infections of the lungs require aggressive antibiotics. Transfusions can sometimes help prevent further damage to the lung tissue. Heart failure can require medications to assist the heart in more effectively pumping blood to the body.

The legs of patients with sickle cell anemia are susceptible to skin breakdown and ulceration. This seems to be a result of the stagnant blood flow caused by the sickled red blood cells. Injury to the skin of the legs or ankles can promote skin damage and ulceration.

Leg ulcers most commonly occur in adults and usually form over the ankles and sides of the lower legs. The ulcers can become severe, even encircling the leg, and are prone to infection.

Leg ulcers can become chronic and resistant to many treatments. Oral antibiotics and topical creams are often used. Elevation of the leg, careful dressing changes, and other topical therapies can be helpful. Some ulcers can be so resistant that skin grafting is recommended, though this may be compromised by impaired healing.

Inadequate circulation of the blood, which is characteristic of sickle cell anemia, also causes areas of death of bone tissue (bone infarction). Aseptic necrosis, or localized bone death, is a result of inadequate oxygen supply to the bone. Aseptic necrosis is also referred to as osteonecrosis.

While virtually any bone can be affected, the most common are the bones of the thighs, legs, and arms. The result can permanently damage or deform the hips, shoulders, or knees. Pain, tenderness, and disability frequently are signs of aseptic necrosis. Painful bone infarcts can be relieved by rest and pain medications.

Aseptic necrosis can permanently damage large joints (such as the hips or shoulders). Local pain can be relieved and worsening of the condition can be prevented by avoiding weight bearing. With more severe damage, total joint replacement may be needed to restore function.

The critical area of the eye that normally senses light is called the retina. The retina is in the back of the eye and is nourished by many tiny blood vessels. Impairment of the circulation from the sickling of red blood cells results in damage to the retina (retinopathy). The result can be partial or complete blindness.

Bleeding can also occur within the eye (retinal hemorrhage) and retinal detachment can result. Retinal detachment can lead to blindness.

Once blindness occurs, it is usually permanent. Preventative measures, such as laser treatments, can be used if bleeding into the eye and retinal detachment are detected early.

Additional features of sickle cell anemia include weakening of bones from osteoporosis, kidney damage and infection, and nervous system damage. Osteoporosis can lead to severe pain in the back and deformity from collapse of the spine (vertebrae). Kidney damage can lead to poor kidney function with a resulting imbalance of blood sodium and acidity as well as bleeding into the urine. Kidney infection can cause pelvic pain and require hospitalization with antibiotic treatment. Injury to the nervous system can result from meningitis or sickle cell anemia itself. Poor blood circulation in the brain can cause stroke, convulsions, and coma.

Damage to the brain from stroke can cause permanent loss of function to areas of the body. Transfusion of blood and fluids intravenously can be critical. Medications to reduce the chance of seizures are sometimes added. If stroke results in long-term impairment of function, physical therapy, speech therapy, and occupational therapy can be helpful.

Priapism, an abnormally persistent erection of the penis in the absence of sexual desire, can occur in persons with sickle cell anemia. Priapism can lead to impotence and damage to affected tissues.

Medically Reviewed by a Doctor on 5/21/2015

Sickle Cell Disease (Sickle Cell Anemia) - Experience Question: Please describe your experience with sickle cell disease (sickle cell anemia).

Sickle Cell Disease (Anemia) - Diagnosis Question: How was your sickle cell anemia diagnosed?

Sickle Cell Disease (Sickle Cell Anemia) - Symptoms Question: At what age did symptoms of sickle cell anemia first appear in someone you know? Please describe other symptoms.

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Sickle Cell Disease (Sickle Cell Anemia ... - MedicineNet

Predatory stem cell clinics are winning the war; what can …

By Stem Cell Clinics

For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool.

A weapon.

As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients and to the larger stem cell community proportionately rises too. We are in a situation today where the dangers from such clinics have never been higher.

They are making millions in profits with little-to-no accountability. Their therapies dont have to work or even be proven safe. Its odd because many consumers seem to expect more from non-health-relatedbusinesses such as McDonalds or computer companies than from stem cell clinics.

Thousands of patients just in the US alone are regularly being subjected to experimental, non-FDA approved interventions. They are spending millions of dollars and being put at substantial risk.

Many patients are desperately looking for hope so they are very driven to find something that may help and are often willing to take unknown risks.

Some of us in the stem cell community are working to try to make some positive impact in this area.I believe we are making a difference, but overallthe dubious stem cell clinics are winning the war.

Why are the clinics prevailing so far?

In part it is because theyve been very smart about how they do business.

For instance, they do PR like pros, they manipulate some members of the media to almost in essence work as their spokespeople, they use social media to great effect, and theyve won over some powerful allies in the form of certain patient advocates who have become in effect stem cell clinic advocates.

An illustration of the cleverness of the clinics is their move to take advantage of Clinicaltrials.gov to list their non-traditional, profit-driven business as if it were real clinical trials. They even go so far as to say that just because their work is listed in that database that their offerings are FDA-approved. They arent.

The stem cell clinics are also winning because the FDA has been so passive and ineffective, particularly during the last two years. Further in the past the FDA and more specifically the CBER division within the FDA that is tasked with dealing with stem cells took steps to regulate the stem cell clinic industry through actions such as warning letters. In contrast, lately CBER hasnt done anything (at least apparent in the public domain and via FOIAs Ive submitted) on the stem cell clinic problem.

This apparent regulatory passivity couldnt come at a worse time either as the stem cell clinics proliferate like crazy in the US. Theres certainly a connection there. Less regulatory action = more dangerous clinics. Its frustrating because CBER of course remains very active with the good citizens of the stem cell world such as those in academia and legit biotechs withappropriately high expectations for them.

Hello, CBER, are you home? Are you paying attention? Patients need to be protected.

Ive tried talking with the FDA to get at the root of the stem cell clinic problem, but things remain nebulous. Are they afraid of being sued? Just too slow? Dont have the budget? Maybe part of the problem is the leadership transition at the FDA where there hasnt been a commissionerbut I think thats only part of the story.

The FDA took a healthy step last year in issuing draft guidance (see my interview here with the FDA on the draft guidance) to regulate fat stem cell products that are almost certainly biological drugs requiring approval, but thats been about it and those draft guidances have not been finalized. Until finalized, the draft guidances have no teeth. Meanwhile the fat stem cell clinics and others that sell unapproved stem cell biologics of various kinds such as amniotics, take advantage of this gray area to milk patients for millions of dollars all the while putting such patients at risk. The clinics are literally laughing at the FDA all the way to the bank.

Why should you care about this as a stem cell researcher, patient advocate, or other interested party? As has happened in the past, people are going to get hurt or killed at these clinics, and not only is that a tragedy unto itself, but also it will reflect badly on the whole stem cell arena. This magnifies the negative impact.

The unchecked stem cell clinic industry also has other negative effects such as muddying the waters for patients over just what is (and what isnt) a legit stem cell therapy and research. We are also seeing some at academic institutions starting to give in to temptation and work with the dubious clinics too probably for the big bucks involved. In short, the war isnt going well and the risks are growing.

So what do to?

We need to push the FDA to act more consistently, quickly, and forcefully on this problem. Maybe they think they are acting on it, but from my view it seems to be in slow motion. A recent poll on my blog indicates a larger sense within the stem cell community that the FDA isnt being effective on stem cell clinics. And by my own calculations, the number of stem cell clinics in the US alone is skyrocketing. The FDA doesnt have much time.

If more patients are injured or even die after getting questionable stem cell therapies, in a sense the FDA will bear part of the blame because of their ineffectiveness.

We also need organizations to step up to the plate and confront the clinics as well. When individuals such as myself and others including Leigh Turner and Doug Sipp do this, we have had some positive impact, but at great risk to ourselves. It is literally dangerous for us. I have been threatened with litigation and literally threatened to be attacked or killed.

Educational efforts can also be helpful and that is a major mission of this blog.

In the absence of timely FDA action, an out of control stem cell free market is churning. In January of thisyear I called it a wild west of medicine. It really feels that way. Theres demand so there will be supply. Something fundamental needs to change or the war is over and patients lose out, as does the stem cell field.

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Scientists reveal how stem cells defend against viruses

By Embryonic Stem Cells

September 21, 2015 Left: Embryonic stem cells with silencing of viruses.Right: Removal of silencing machineries Cha1fa and Sumo2 resulting in the activation of viruses (in green). Credit: Jonathan Loh, A*STAR's Institute of Molecular and Cell Biology

Scientists from the Institute of Molecular and Cell Biology (IMCB), a research institute under the Agency for Science, Technology and Research (A*STAR), Singapore, have uncovered the mechanisms which embryonic stem cells employ to inhibit virus expression. The ground-breaking discovery could potentially advance stem cell therapeutics and diagnostics.

Several stem cell types including embryonic and haematopoietic stem cells are known to be capable of suppressing the activities of infected viruses and viral DNA residing in the host genome. This characteristic property, known as proviral silencing, however, has not been fully understood. In order to study this, a team of scientists from IMCB designed a novel assay which allowed them to screen all the genes present in embryonic stem cells.

Through the screening platform, the team identified 303 genes and elucidated 148 biological processes and pathways linked to proviral silencing, suggesting that proviral silencing is controlled by coordinated mechanisms involving multiple cellular pathways. Through a comprehensive analysis, the scientists concluded that two specific genes, Chaf1a and Sumo2, are the key factors linked to proviral silencing. The findings of the study were reported in the top-tier scientific journal, Cell.

Further studies on the roles of Chaf1a and Sumo2 in stem cell proviral silencing can shed new light on stem cells and virus biology that could translate into valuable therapeutic and diagnostic applications.

Dr Jonathan Loh, Principal Investigator of IMCB, said, "This is the first detailed study on proviral silencing in embryonic stem cells, and it helped us gain a deeper understanding of stem cells and its unique proviral silencing ability. With the new insights, we can better identify the good stem cells and use them more efficiently and safely in clinical therapies. We can also devise diagnostic approaches by studying the activities of the virus DNA within stem cells in various diseased conditions."

Prof Hong Wanjin, Executive Director of IMCB, said, "Fundamental research on human biology seeks to understand crucial biological processes occurring within humans in order to bring advancement in therapeutics and improve lives. With the growing importance of stem cell therapy, this study is a fitting example of how upstream research can potentially benefit and shape its applications."

Explore further: Stem cells born out of indecision

More information: Systematic Identification of Factors for Provirus Silencing in Embryonic Stem Cells, http://www.cell.com/cell/abstract/S0092-8674%2815%2901089-2

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Singapore scientists from A*STAR's Genome Institute of Singapore (GIS) have, for the first time, found further evidence of how the differentiation of pluripotent cells is tied to and controlled by the cell cycle clock. This ...

The importance of a chromatin remodeler gene, Chd1, in regulating the ability of embryonic stem cells to develop into other cell types has been revealed in a new study by A*STAR researchers.

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According to a well-known theory in evolutionary biology healthy females should give birth to more males than females. A study funded by the Swiss National Science Foundation shows why this is not always true.

We each give off millions of bacteria from our human microbiome to the air around us every day, and that cloud of bacteria can be traced back to an individual. New research focused on the personal microbial cloudthe airborne ...

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Scientists reveal how stem cells defend against viruses

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Sofie Bhatti, Luisa De Risio, Karen Muana, Jacques Penderis, Veronika Stein, Andrea Tipold, Mette Berendt, Robyn Farquhar, Andrea Fischer, Sam Long, Wolfgang Lscher, Paul Mandigers, Kaspar Matiasek, Akos Pakozdy, Edward Patterson, Simon Platt, Michael Podell, Heidrun Potschka, Clare Rusbridge, Holger Volk BMC Veterinary Research 2015, 11:176 (28 August 2015)

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International Veterinary Epilepsy Task Forces current understanding of idiopathic epilepsy of genetic or suspected genetic origin in purebred dogs

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International Veterinary Epilepsy Task Force consensus reports on epilepsy definition, classification and terminology, affected dog breeds, diagnosis, treatment, outcome measures of therapeutic trials, neuroimaging and neuropathology in companion animals

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International veterinary epilepsy task force consensus proposal: diagnostic approach to epilepsy in dogs

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Has the FDA given up on regulating stem cell clinics …

By Stem Cell Clinic

What the heck happened to the FDA when it comes to regulating stem cell clinics?

Has it given up?

Or does it just seem that way because it moves in slow motion?

The FDA might as well have thrown in the towelbecause, as I like to say, the stem cell field moves in dog years. Often times 7 years worth of stem cell happenings take place in just onehuman calendar year. An example of this warp speed is the approximate doubling of the number of stem cell clinics in the US in the last year or so.

There was a time when I was perhaps naive enough thatI thought that regulatory agencies legally tasked with oversight of biologics would take swift action against violators, particularly if the products or procedures in question were not proven to be safe or effective. Patients are at serious risk.

Throw in some evidence of predatory behavior and dubious public claims and lack of training at some clinics, and the FDA in the US, for example, surely would do something about it as thousands of patients get these dubious interventions. Right?

Im no so sure anymore.

I still believe in appropriate regulation of stem cell-based medical products and interventions.The FDA has now won their recent legal case on regulating proliferated stem cell products as biological drugs and it would seem they should if anything be energized to put the stem cell clinic sphere in order.

Cue crickets chirping.

The FDA appears at least on the surface not to be doing much of anything on stem cell clinics even as the number of dubious stem cell clinics in the US has stormed past 100. One problem right up the FDAs alley for regulation is that these places are selling and using unapproved products and devices, and in that way putting patients at serious risk. For example, as best as I can tell there has been no recent FDA action on stromal vascular fraction (SVF), a product that the FDA has, at least in the past, defined in no uncertain terms as a biological drug. Meanwhile more and moreclinics sell SVF treatments and it isspiraling out of control.

What is happening as a result of this lack of action by the FDA is bad for the stem cell field and for biomedical science more generally in addition to putting patients at risk as they literally pay to be participants in unapproved, for-profit human experiments. The reputation of the stem cell field overall is also in jeopardy.

Its a weird situation. On the one hand the FDA holds those with good intentions (e.g. biotech and academic researchers working to do clinical trials) to appropriate, relatively strict standards, but on the other hand turns an apparent blind eye to an entire unregulated industry of stem cell clinics.

Even as the number of dubious clinics rockets upward, in the past year or so the FDA has issued no warning letters in this sphere and as best as I can tell not done much of anything. If the lack of FDA action meant that the stem cell clinic sphere was becoming more responsible and safer then Id be cheering that, but instead I think it reflects some change at the FDA that is not encouraging.

The FDA has a unique opportunity to do something to help remedy this situation and clarify the regulatory sphere related to stem cells this year as it is slated to release new guidance sometime in 2014 on amongst other things SVF and other fat stem cell products. Will they punt? Will they stand firm? At this point, its anybodys guess.

Here are the pertinent sections to focus on in the page linked to above:

The FDA tells me they are taking actual actions too in this arena, but they cannot discuss it and the action is not apparent in the public sphereyet.

However, effectively their inaction or slow motion action has created what I have termed default deregulation and this will only become more entrenched as the number of dubious clinics and untrained physicians pitching stem cell interventions without regulatory approval continues to skyrocket.

I often talk to the clinics and as appropriate I sometimes tell them they are not following FDA regulations, etc.

Im not sure if I can even say that anymore since the FDA seems to be in effective hibernation on stem cell clinics.

Are the clinic operators right they can pretty much do whatever they want with whatever devices and products they feel like without worrying about the FDA? Im not sure anymore because it feels like the FDA is all talk and no action lately on stem cell clinics. Well, actually, no talk and no action.

. Bookmark the

.

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Has the FDA given up on regulating stem cell clinics ...

Stem Cell Treatment May Help Ease Osteoarthritis Pain …

By Uncategorized

Last year, Patricia Beals was told she'd need a double knee replacement to repair her severely arthritic knees or she'd probably spend the rest of her life in a wheelchair.

Hoping to avoid surgery, Beals, 72, opted instead for an experimental treatment that involved harvesting bone marrow stem cells from her hip, concentrating the cells in a centrifuge and injecting them back into her damaged joints.

"Almost from the moment I got up from the table, I was able to throw away my cane," Beals says. "Now I'm biking and hiking like a 30-year-old."

A handful of doctors around the country are administering treatments like the one Beals received to stop or even reverse the ravages of osteoarthritis. Stem cells are the only cells in the body able to morph into other types of specialized cells. When the patient's own stem cells are injected into a damaged joint, they appear to transform into chondrocytes, the cells that go on to produce fresh cartilage. They also seem to amplify the body's own natural repair efforts by accelerating healing, reducing inflammation, and preventing scarring and loss of function.

Christopher J. Centeno, M.D., the rehab medicine specialist who performed Beals' procedure, says the results he sees from stem cell therapy are remarkable. Of the more-than-200 patients his Bloomfield, Colo., clinic treated over a two-year period, he says, "two thirds of them reported greater than 50 percent relief and about 40 percent reported more than 75 percent relief one to two years afterward."

According to Centeno, knees respond better to the treatment than hips. Only eight percent of his knee patients opted for a total knee replacement two years after receiving a stem cell injection. The complete results from his clinical observations will be published in a major orthopedic journal later this year.

The Pros and Cons

The biggest advantage stem cell injections seem to offer over more invasive arthritis remedies is a quicker, easier recovery. The procedure is done on an outpatient basis and the majority of patients are up and moving within 24 hours. Most wear a brace for several weeks but still can get around. Many are even able to do some gentle stationary cycling by the end of the first week.

There are also fewer complications. A friend who had knee replacement surgery the same day Beals had her treatment developed life-threatening blood clots and couldn't walk for weeks afterwards. Six months out, she still hasn't made a full recovery.

Most surgeries don't go so awry, but still: Beals just returned from a week-long cycling trip where she covered 20 to 40 miles per day without so much as a tweak of pain.

As for risks, Centeno maintains they are virtually nonexistent.

"Because the stem cells come from your own body, there's little chance of infection or rejection," he says.

Not all medical experts are quite so enthusiastic, however. Dr. Tom Einhorn, chairman of the department of orthopedic surgery at Boston University, conducts research with stem cells but does not use them to treat arthritic patients. He thinks the idea is interesting but the science is not there yet.

"We need to have animal studies and analyze what's really happening under the microscope. Then, and only then, can you start doing this with patients," he says.

The few studies completed to date have examined how stem cells heal traumatic injuries rather than degenerative conditions such as arthritis. Results have been promising but, as Einhorn points out, the required repair mechanisms in each circumstance are very different.

Another downside is cost: The injections aren't approved by the FDA, which means they aren't covered by insurance. At $4,000 a pop -- all out of pocket -- they certainly aren't cheap, and many patients require more than one shot.

Ironically, one thing driving up the price is FDA involvement. Two years ago, the agency stepped in and stopped physicians from intensifying stem cells in the lab for several days before putting them back into the patient. This means all procedures must be done on the same day, no stem cells may be preserved and many of the more expensive aspects of the treatment must be repeated each time.

Centeno says same day treatments often aren't as effective, either.

But despite the sky-high price tag and lack of evidence, patients like Beals believe the treatment is nothing short of a miracle. She advises anyone who is a candidate for joint replacement to consider stem cells first.

"Open your mind up and step into it," she says. "Do it. It's so effective. It's the future and it works."

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Stem Cell Treatment May Help Ease Osteoarthritis Pain ...

Pluripotent Stem Cells 101 | Boston Children’s Hospital

By Induced Pluripotent Stem Cells

Pluripotent stem cells are master cells. Theyre able to make cells from all three basic body layers, so they can potentially produce any cell or tissue the body needs to repair itself. This master property is called pluripotency. Like all stem cells, pluripotent stem cells are also able to self-renew, meaning they can perpetually create more copies of themselves.

There are several types of pluripotent stem cells, including embryonic stem cells. At Childrens Hospital Boston, we use the broader term because pluripotent stem cells can come from different sources, and each method creates a cell with slightly different properties.

But all of them are able to differentiate, or mature, into the three primary groups of cells that form a human being:

Right now, its not clear which type or types of pluripotent stem cells will ultimately be used to create cells for treatment, but all of them are valuable for research purposes, and each type has unique lessons to teach scientists. Scientists are just beginning to understand the subtle differences between the different kinds of pluripotent stem cells, and studying all of them offers the greatest chance of success in using them to help patients.

Types of pluripotent stem cells:

All four types of pluripotent stem cells are being actively studied at Childrens.

Induced pluripotent cells (iPS cells): Scientists have discovered ways to take an ordinary cell, such as a skin cell, and reprogram it by introducing several genes that convert it into a pluripotent cell. These genetically reprogrammed cells are known as induced pluripotent cells, or iPS cells. The Stem Cell Program at Childrens Hospital Boston was one of the first three labs to do this in human cells, an accomplishment cited as the Breakthrough of the Year in 2008 by the journal Science.

iPS cells offer great therapeutic potential. Because they come from a patients own cells, they are genetically matched to that patient, so they can eliminate tissue matching and tissue rejection problems that currently hinder successful cell and tissue transplantation. iPS cells are also a valuable research tool for understanding how different diseases develop.

Because iPS cells are derived from skin or other body cells, some people feel that genetic reprogramming is more ethical than deriving embryonic stem cells from embryos or eggs. However, this process must be carefully controlled and tested for safety before its used to create treatments. In animal studies, some of the genes and the viruses used to introduce them have been observed to cause cancer. More research is also needed to make the process of creating iPS cells more efficient.

iPS cells are of great interest at Childrens, and the lab of George Q. Daley, MD, PhD, Director of Stem Cell Transplantation Program, reported creating 10 disease-specific iPS lines, the start of a growing repository of iPS cell lines.

Embryonic stem cells: Scientists use embryonic stem cell as a general term for pluripotent stem cells that are made using embryos or eggs, rather than for cells genetically reprogrammed from the body. There are several types of embryonic stem cells:

1. True embryonic stem cell (ES cells) These are perhaps the best-known type of pluripotent stem cell, made from unused embryos that are donated by couples who have undergone in vitro fertilization (IVF). The IVF process, in which the egg and sperm are brought together in a lab dish, frequently generates more embryos than a couple needs to achieve a pregnancy.

These unused embryos are sometimes frozen for future use, sometimes made available to other couples undergoing fertility treatment, and sometimes simply discarded, but some couples choose to donate them to science. For details on how theyre turned into stem cells, visit our page How do we get pluripotent stem cells?

Pluripotent stem cells made from embryos are generic and arent genetically matched to a particular patient, so are unlikely to be used to create cells for treatment. Instead, they are used to advance our knowledge of how stem cells behave and differentiate.

2. Stem cells made by somatic cell nuclear transfer (ntES cells) The term somatic cell nuclear transfer (SCNT) means, literally, transferring the nucleus (which contains all of a cells genetic instructions) from a somatic cellany cell of the bodyto another cell, in this case an egg cell. This type of pluripotent stem cell, sometimes called an ntES cell, has only been made successfully in lower animals. To make ntES cells in human patients, an egg donor would be needed, as well as a cell from the patient (typically a skin cell).

The process of transferring a different nucleus into the egg reprograms it to a pluripotent state, reactivating the full set of genes for making all the tissues of the body. The egg is then allowed to develop in the lab for several days, and pluripotent stem cells are derived from it. (Read more in How do we get pluripotent stem cells?)

Like iPS cells, ntES cells match the patient genetically. If created successfully in humans, and if proven safe, ntES cells could completely eliminate tissue matching and tissue rejection problems. For this reason, they are actively being researched at Childrens.

3. Stem cells from unfertilized eggs (parthenogenetic embryonic stem cells) Through chemical treatments, unfertilized eggs can be tricked into developing into embryos without being fertilized by sperm, a process called parthenogenesis. The embryos are allowed to develop in the lab for several days, and then pluripotent stem cells can be derived from them (for more, see How do we get pluripotent stem cells?)

If this technique is proven safe, a woman might be able to donate her own eggs to create pluripotent stem cells matching her genetically that in turn could be used to make cells that wouldnt be rejected by her immune system.

Through careful genetic typing, it might also be possible to use pES cells to create treatments for patients beyond the egg donor herself, by creating master banks of cells matched to different tissue types. In 2006, working with mice, Childrens researchers were the first to demonstrate the potential feasibility of this approach. (For details, see Turning pluripotent stem cells into treatment).

Because pES cells can be made more easily and more efficiently than ntES cells, they could potentially be ready for clinical use sooner. However, more needs to be known about their safety. Concerns have been raised that tissues derived from them might not function normally.

Read more about pluripotent stem cells by following these links:

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Pluripotent Stem Cells 101 | Boston Children's Hospital

PRP Therapy (Platelet-Rich Plasma) – JointRehab.com

By Platelet Rich Plasma Injections

Although PRP (Platelet-Rich Plasma) Therapy has been around since the mid-1990s many people are still unaware of this beneficial treatment.

Various fields of medicine, including dentistry, neurosurgery, wound healing, and orthopedics, have only just begun to scrape the surface of the long-term and ongoing benefits that can result from employing this valuable therapy.

What is it? A Quick Lesson on Blood In a nutshell, a PRP injection delivers a high concentration of endogenous (your own home-grown) platelets to an area of injury.

To understand the therapeutic value of PRP injections, you need to have a basic understanding of the make-up of blood. Blood is composed of plasma, red blood cells, white blood cells, and platelets. Its these platelets that are the injurys first-responders and help revascularize an injured area, construct new tissue, and stop the bleeding.

Because platelets play a significant role in the healing of tissue, reintroducing a high concentration of platelets directly into the injured area may enhance the healing process.

The physiological effects include:

Increase tissue regeneration (tendon, ligament, soft tissue) Decrease inflammation Decrease pain Increase collagen (base component of connective tissue) Increase bone density Increase angiogenesis (development of new blood cells)

In the world of high-stakes sports, many stars swear by it. Tiger Woods received PRP injections in his left knee following surgery, and L.A. Dodgers pitcher, Takashi Saito was able to return to the mound for the 2008 playoffs as a result of this little-known therapy.

Studies have seconded these testimonials. A recent study published in the American Journal of Sports Medicine (2006) reviewed the effectiveness of PRP therapy in patients with chronic elbow pain. Fifteen patients were treated with PRP therapy. The results documented a 60% improvement at eight weeks, 81% at six months, and 93% at final follow-up (12-38 months). There were no side effects or complications reported.

The Trouble with Tendons Tendon injuries often become chronic because of the poor blood supply to these areas. Athletes and active people tend to have these issues and sometimes a whole career or hobby can be ruined by this ongoing complication. A PRP injection allows a quick and focused action to the area of injury, which allows it to heal more effectively and rapidly.

The Procedure A patients blood is drawn and placed in a centrifuge which separates the platelet-rich plasma from the rest of the blood. This plasma is then injected into the area of injury. Its a quick procedure with little, if any, downtime. Its also safe because the platelets are derived from the patients own blood, so there is no risk of rejection or reaction.

Not every patient is treated with PRP. We do not treat every patient with PRP, most often, Dextrose Prolotherapy is used instead of PRP, because of the extra step in drawing your blood, the extra expense in purchasing the PRP kit, and extra time it takes to prepare the platelets. The injections are exactly the same way, but the proliferant, or solution injected is different. For many years we have had great success in healing 1000s of patients and having them avoid surgery with dextrose Prolotherapy.

Your decision to have PRP should be discussed with us to determine which type of Prolotherapy, (Dextrose, platelets, or another proliferant) is best for you.

Not every doctor is proficient in PRP Therapy Platelet Rich Plasma Therapy has become very popular. Physicians who do not do traditional Prolotherapy are now offering PRP. Unfortunately, these untrained doctors are injecting the platelets in a way that is often painful, debilitating for weeks, and can leave hematomas (collections of clotted blood) in the area injected. We believe that PRP is best delivered by a physician already experienced and well versed in Prolotherapy.

Platelet alpha granules contain potent growth factors necessary to begin tissue repair and regeneration at the wound site. Concentrated autologous platelets contain large reservoirs of growth factors that have the potential to greatly accelerate the normal healing process, naturally. The use of concentrated growth factors is considered by many to be a new frontier of clinical therapy

Excerpts in this article from Harvest Technologies Corp

1. Marx, R.E. , et al,Platelet-Rich Plasma Growth Factor Enhancement for Bone Grafts, Oral Surg Oral Med Oral Patrhol, 1998;85:638-646.

2. Antonaides, H.N., et al,Human Platelet-Derived Growth Factor: Structure and Functions, Federation Proceedings, 1983;42:2630-2634.

3. Pierce, G.F., et al,PDGF-BB,TGF-1 and Basic FGF in Dermal Wound Healing: Neovessel and Matrix Formation and Cessation Repair, Am J Pathology, 1992;140:1375-1388.

Marc Darrow, M.D., J.D., utilizes Stem Cell Therapy, Platatelt Rich Plasma Therapy, and Prolotherapy for the treatment of chronoc joint and back pain. Dr. Marc Darrow is a Board Certified Physiatrist specializing in Physical Medicine and Rehabilitation.

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PRP Therapy (Platelet-Rich Plasma) - JointRehab.com

Stem Cells News — ScienceDaily

By Stem Cell Medicine

Sep. 3, 2015 A number of illnesses causing blindness can be cured from transplanting cells from the oral cavity. New findings make the treatment accessible to the places where the condition strikes the most ... read more Aug. 26, 2015 Compounds found in purple potatoes may help kill colon cancer stem cells and limit the spread of the cancer, according to a team of ... read more Aug. 20, 2015 Scientists have developed a novel way to engineer the growth and expansion of energy-burning 'good' fat, and then found that this fat helped reduce weight gain and lower blood glucose ... read more How Newts Can Help Osteoarthritis Patients Aug. 20, 2015 Osteoarthritis is the most common form of joint disease worldwide. Now, scientists have taken a leaf out of natures book in an attempt to develop effective stem cell treatment for osteoarthritis, ... read more Regenerating Nerve Tissue in Spinal Cord Injuries Aug. 13, 2015 Researchers are exploring a new therapy using stem cells to treat spinal cord injuries within the first 14 to 30 days of injury. The therapy uses a population of cells derived from human embryonic ... read more Newly Discovered Cells Regenerate Liver Tissue Without Forming Tumors Aug. 13, 2015 The mechanisms that allow the liver to repair and regenerate itself have long been a matter of debate. Now researchers have discovered a population of liver cells that are better at regenerating ... read more Aug. 12, 2015 Scientists have discovered metabolic rejuvenation factors in eggs. This critical finding furthers our understanding of how cellular metabolism changes during aging, and during rejuvenation after egg ... read more Can Stem Cells Cause and Cure Cancer? Aug. 12, 2015 Simply put, cancer is caused by mutations to genes within a cell that lead to abnormal cell growth. Finding out what causes that genetic mutation has been the holy grail of medical science for ... read more Why Statins Should Be Viewed as a Double-Edged Sword Aug. 12, 2015 Statins have significant cardiovascular benefits, but also serious side effects. A new study finds that statin use impairs stem cell function, which helps in slowing atherosclerosis but hinders other ... read more Researcher Studying Advances in Next-Generation Stem Cell Culture Technologies Aug. 10, 2015 A researcher is studying ways to advance the next generation of cell culture technologiesthe removal of stem cells from an organism and the controlled growth of those cells in an engineering ... read more Stem Cells Help Researchers Study the Effects of Pollution on Human Health Aug. 10, 2015 Embryonic stem cells could serve as a model to evaluate the physiological effects of environmental pollutants efficiently and cost-effectively. The use of stem cells has found another facade. In the ... read more Aug. 5, 2015 Scientists have, for the first time, found further evidence of how the differentiation of pluripotent cells is tied to and controlled by the cell cycle clock. This deeper understanding of how cells ... read more From Pluripotency to Totipotency Aug. 4, 2015 While it is already possible to obtain in vitro pluripotent cells (i.e., cells capable of generating all tissues of an embryo) from any cell type, researchers have pushed the limits of science even ... read more Precision Medicine Brought One Step Closer to the Clinic Aug. 3, 2015 A revolutionary, high-throughput, robotic platform has been designed that automates and standardizes the process of transforming patient samples into stem cells. This unique platform for the first ... read more Aug. 3, 2015 Investigators report that they have been able to drive cells to grow into muscle fibers, producing millimeter-long muscle fibers capable of contracting in a dish and multiplying in large numbers. ... read more July 30, 2015 Evaluating drug-induced liver injury is a critical part of pharmaceutical drug discovery and must be carried out on human liver cells. Now, scientists report that they produced large amounts of ... read more How a Single Molecule Turns One Immune Cell Into Another July 30, 2015 All it takes is one molecule to reprogram an antibody-producing B cell into a scavenging macrophage. This transformation is possible, new evidence shows, because the molecule (C/EBPa, a transcription ... read more July 29, 2015 A first-of-its kind prostate 'organoid' grown from human embryonic stem cells has enabled researchers to show that exposure to bisphenol A, a chemical in many plastics, can cause ... read more Scientists Identify Gene Vital for Rebuilding Intestine After Cancer Treatment July 29, 2015 A rare type of stem cell is immune to radiation damage thanks to high levels of a gene called Sox9, researchers have ... read more New Drug for Blood Cancers Now in Five Phase II Clinical Trials July 28, 2015 The safety and dosing of a new drug for treating blood cancers has now been established by a group of scientists. The drug is a small molecule inhibitor that suppresses the activity of a signaling ... read more

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