Hairy cell leukemia – Wikipedia

Hairy cell leukemia is an uncommon hematological malignancy characterized by an accumulation of abnormal B lymphocytes. It is usually classified as a sub-type of chronic lymphoid leukemia. Hairy cell leukemia makes up approximately 2% of all leukemias, with fewer than 2,000 new cases diagnosed annually in North America and Western Europe combined.

Hairy cell leukemia was originally described as histiocytic leukemia, malignant reticulosis, or lymphoid myelofibrosis in publications dating back to the 1920s. The disease was formally named leukemic reticuloendotheliosis and its characterization significantly advanced by Bertha Bouroncle and colleagues at The Ohio State University College of Medicine in 1958. Its common name, which was coined in 1966,[1] is derived from the "hairy" appearance of the malignant B cells under a microscope.

In hairy cell leukemia, the "hairy cells" (malignant B lymphocytes) accumulate in the bone marrow, interfering with the production of normal white blood cells, red blood cells, and platelets. Consequently, patients may develop infections related to low white blood cell count, anemia and fatigue due to a lack of red blood cells, or easy bleeding due to a low platelet count.[2] Leukemic cells may gather in the spleen and cause it to swell; this can have the side effect of making the person feel full even when he or she has not eaten much.

Hairy cell leukemia is commonly diagnosed after a routine blood count shows unexpectedly low numbers of one or more kinds of normal blood cells, or after unexplained bruises or recurrent infections in an otherwise apparently healthy patient.

Platelet function may be somewhat impaired in HCL patients, although this does not appear to have any significant practical effect.[3] It may result in somewhat more mild bruises than would otherwise be expected for a given platelet count or a mildly increased bleeding time for a minor cut. It is likely the result of producing slightly abnormal platelets in the overstressed bone marrow tissue.

Patients with a high tumor burden may also have somewhat reduced levels of cholesterol,[4] especially in patients with an enlarged spleen.[5] Cholesterol levels return to more normal values with successful treatment of HCL.

As with many cancers, the cause of hairy cell leukemia is unknown. Exposure to tobacco smoke, ionizing radiation, or industrial chemicals (with the possible exception of diesel) does not appear to increase the risk of developing HCL.[6] Farming and gardening appear to increase the risk of HCL in some studies.[7]

Recent studies have identified somatic BRAF V600E mutations in all patients with the classic form of hairy cell leukemia thus sequenced, but in no patients with the variant form.[8]

The U.S. Institute of Medicine (IOM) announced "sufficient evidence" of an association between exposure to herbicides and later development of chronic B-cell leukemias and lymphomas in general. The IOM report emphasized that neither animal nor human studies indicate an association of herbicides with HCL specifically. However, the IOM extrapolated data from chronic lymphocytic leukemia and non-Hodgkin lymphoma to conclude that HCL and other rare B-cell neoplasms may share this risk factor.[9] As a result of the IOM report, the U.S. Department of Veterans Affairs considers HCL an illness presumed to be a service-related disability (see Agent Orange).

Human T-lymphotropic virus 2 (HTLV-2) has been isolated in a small number of patients with the variant form of HCL.[10] In the 1980s, HTLV-2 was identified in a patient with a T-cell lymphoproliferative disease; this patient later developed hairy cell leukemia (a B cell disease), but HTLV-2 was not found in the hairy cell clones.[11] There is no evidence that HTLV-II causes any sort of hematological malignancy, including HCL.[12]

The diagnosis of HCL may be suggested by abnormal results on a complete blood count (CBC), but additional testing is necessary to confirm the diagnosis. A CBC normally shows low counts for white blood cells, red blood cells, and platelets in HCL patients. However, if large numbers of hairy cells are in the blood stream, then normal or even high lymphocyte counts may be found.

On physical exam, 8090% of patients have an enlarged spleen, which can be massive.[13] This is less likely among patients who are diagnosed at an early stage. Peripheral lymphadenopathy (enlarged lymph nodes) is uncommon (less than 5% of patients), but abdominal lymphadenopathy is a relatively common finding on computed tomography (CT) scans.[13]

The most important lab finding is the presence of hairy cells in the bloodstream.[13] Hairy cells are abnormal white blood cells with hair-like projections of cytoplasm; they can be seen by examining a blood smear or bone marrow biopsy specimen. The blood film examination is done by staining the blood cells with Wright's stain and looking at them under a microscope. Hairy cells are visible in this test in about 85% of cases.[13]

Most patients require a bone marrow biopsy for final diagnosis. The bone marrow biopsy is used both to confirm the presence of HCL and also the absence of any additional diseases, such as Splenic marginal zone lymphoma or B-cell prolymphocytic leukemia. The diagnosis can be confirmed by viewing the cells with a special stain known as TRAP (tartrate resistant acid phosphatase).

It is also possible to definitively diagnose hairy cell leukemia through flow cytometry on blood or bone marrow. The hairy cells are larger than normal and positive for CD19, CD20, CD22, CD11c, CD25, CD103, and FMC7.[14] (CD103, CD22, and CD11c are strongly expressed.)[15]

Hairy cell leukemia-variant (HCL-V), which shares some characteristics with B cell prolymphocytic leukemia (B-PLL), does not show CD25 (also called the Interleukin-2 receptor, alpha). As this is relatively new and expensive technology, its adoption by physicians is not uniform, despite the advantages of comfort, simplicity, and safety for the patient when compared to a bone marrow biopsy. The presence of additional lymphoproliferative diseases is easily checked during a flow cytometry test, where they characteristically show different results.[16]

The differential diagnoses include: several kinds of anemia, including myelophthisis and aplastic anemia,[17] and most kinds of blood neoplasms, including hypoplastic myelodysplastic syndrome, atypical chronic lymphocytic leukemia, B-cell prolymphocytic leukemia, or idiopathic myelofibrosis.[16]

When not further specified, the "classic" form is often implied. However, two variants have been described: Hairy cell leukemia-variant[18] and a Japanese variant. The non-Japanese variant is more difficult to treat than either 'classic' HCL or the Japanese variant HCL.

Hairy cell leukemia-variant, or HCL-V, is usually described as a prolymphocytic variant of hairy cell leukemia.[19] It was first formally described in 1980 by a paper from the University of Cambridge's Hayhoe lab.[20] About 10% of people with HCL have this variant form of the disease, representing about 60-75 new cases of HCL-V each year in the U.S. While classic HCL primarily affects men, HCL-V is more evenly divided between males and females.[21] While the disease can appear at any age, the median age at diagnosis is over 70.[22]

Similar to B-cell prolymphocytic leukemia ("B-PLL") in Chronic lymphocytic leukemia, HCL-V is a more aggressive disease. Historically, it has been considered less likely to be treated successfully than is classic HCL, and remissions have tended to be shorter.

However, the introduction of combination therapy with concurrent rituximab and cladribine therapy has shown excellent results in early follow-up.[23] As of 2016, this therapy is considered the first-line treatment of choice for many people with HCL-V.[24]

Many older treatment approaches, such as Interferon-alpha, the combination chemotherapy regimen "CHOP", and common alkylating agents like cyclophosphamide showed very little benefit.[21] Pentostatin and cladribine administered as monotherapy (without concurrent rituximab) provide some benefit to many people with HCL-V, but typically induce shorter remission periods and lower response rates than when they are used in classic HCL. More than half of people respond partially to splenectomy.[21]

In terms of B-cell development, the prolymphocytes are less developed than are lymphocytes or plasma cells, but are still more mature than their lymphoblastic precursors.

HCL-V differs from classic HCL principally in the following respects:

Low levels of CD25, a part of the receptor for a key immunoregulating hormone, may explain why HCL-V cases are generally much more resistant to treatment by immune system hormones.[19]

HCL-V, which usually features a high proportion of hairy cells without a functional p53 tumor suppressor gene, is somewhat more likely to transform into a higher-grade malignancy. A typical transformation rate of 5%-6% has been postulated in the U.K., similar to the Richter's transformation rate for SLVL and CLL.[21][27] Among HCL-V patients, the most aggressive cases normally have the least amount of p53 gene activity.[28] Hairy cells without the p53 gene tend, over time, to displace the less aggressive p53(+) hairy cells.

There is some evidence suggesting that a rearrangement of the immunoglobulin gene VH4-34, which is found in about 40% of HCL-V patients and 10% of classic HCL patients, may be a more important poor prognostic factor than variant status, with HCL-V patients without the VH4-34 rearrangement responding about as well as classic HCL patients.[29]

Hairy cell leukemia-Japanese variant or HCL-J. There is also a Japanese variant, which is more easily treated.

Treatment with cladribine has been reported.[30]

Pancytopenia in HCL is caused primarily by marrow failure and splenomegaly. Bone marrow failure is caused by the accumulation of hairy cells and reticulin fibrosis in the bone marrow, as well as by the detrimental effects of dysregulated cytokine production.[13] Splenomegaly reduces blood counts through sequestration, marginalization, and destruction of healthy blood cells inside the spleen.[13]

Hairy cells are nearly mature B cells, which are activated clonal cells with signs of VH gene differentiation.[16] They may be related to pre-plasma marginal zone B cells[13] or memory cells.

Cytokine production is disturbed in HCL. Hairy cells produce and thrive on TNF-alpha.[13] This cytokine also suppresses normal production of healthy blood cells in the bone marrow.[13]

Unlike healthy B cells, hairy cells express and secrete an immune system protein called Interleukin-2 receptor (IL-2R).[13] In HCL-V, only part of this receptor is expressed.[13] As a result, disease status can be monitored by measuring changes in the amount of IL-2R in the blood serum.[13] The level increases as hairy cells proliferate, and decreases when they are killed. Although uncommonly used in North America and northern Europe, this test correlates better with disease status and predicts relapse more accurately than any other test.

Hairy cells respond to normal production of some cytokines by T cells with increased growth. Treatment with Interferon-alpha suppresses the production of this pro-growth cytokine from T cells.[13] A low level of T cells, which is commonly seen after treatment with cladribine or pentostatin, and the consequent reduction of these cytokines, is also associated with reduced levels of hairy cells.

In June 2011, E Tiacci et al[31][32] discovered that 100% of hairy-cell leukaemia samples analysed had the oncogenic BRAF mutation V600E, and proposed that this is the disease's driver mutation. Until this point, only a few genomic imbalances had been found in the hairy cells, such as trisomy 5 had been found.[13] The expression of genes is also dysregulated in a complex and specific pattern. The cells underexpress 3p24, 3p21, 3q13.3-q22, 4p16, 11q23, 14q22-q24, 15q21-q22, 15q24-q25, and 17q22-q24 and overexpress 13q31 and Xq13.3-q21.[33] It has not yet been demonstrated that any of these changes have any practical significance to the patient.

Several treatments are available, and successful control of the disease is common.

Not everyone needs treatment. Treatment is usually given when the symptoms of the disease interfere with the patient's everyday life, or when white blood cell or platelet counts decline to dangerously low levels, such as an absolute neutrophil count below one thousand cells per microliter (1.0 K/uL). Not all patients need treatment immediately upon diagnosis, and about 10% of patients will never need treatment.

Treatment delays are less important than in solid tumors. Unlike most cancers, treatment success does not depend on treating the disease at an early stage. Because delays do not affect treatment success, there are no standards for how quickly a patient should receive treatment. However, waiting too long can cause its own problems, such as an infection that might have been avoided by proper treatment to restore immune system function. Also, having a higher number of hairy cells at the time of treatment can make certain side effects somewhat worse, as some side effects are primarily caused by the body's natural response to the dying hairy cells. This can result in the hospitalization of a patient whose treatment would otherwise be carried out entirely at the hematologist's office.

Single-drug treatment is typical. Unlike most cancers, only one drug is normally given to a patient at a time. While monotherapy is normal, combination therapytypically using one first-line therapy and one second-line therapyis being studied in current clinical trials and is used more frequently for refractory cases. Combining rituximab with cladribine or pentostatin may or may not produce any practical benefit to the patient.[34] Combination therapy is almost never used with a new patient. Because the success rates with purine analog monotherapy are already so high, the additional benefit from immediate treatment with a second drug in a treatment-nave patient is assumed to be very low. For example, one round of either cladribine or pentostatin gives the median first-time patient a decade-long remission; the addition of rituximab, which gives the median patient only three or four years, might provide no additional value for this easily treated patient. In a more difficult case, however, the benefit from the first drug may be substantially reduced and therefore a combination may provide some benefit.

Cladribine (2CDA) and pentostatin (DCF) are the two most common first-line therapies. They both belong to a class of medications called purine analogs, which have mild side effects compared to traditional chemotherapy regimens.

Cladribine can be administered by injection under the skin, by infusion over a couple of hours into a vein, or by a pump worn by the patient that provides a slow drip into a vein, 24 hours a day for 7 days. Most patients receive cladribine by IV infusion once a day for five to seven days, but more patients are being given the option of taking this drug once a week for six weeks. The different dosing schedules used with cladribine are approximately equally effective and equally safe.[35] Relatively few patients have significant side effects other than fatigue and a high fever caused by the cancer cells dying, although complications like infection and acute kidney failure have been seen.

Pentostatin is chemically similar to cladribine, and has a similar success rate and side effect profile, but it is always given over a much longer period of time, usually one dose by IV infusion every two weeks for three to six months.

During the weeks following treatment the patient's immune system is severely weakened, but their bone marrow will begin to produce normal blood cells again. Treatment often results in long-term remission. About 85% of patients achieve a complete response from treatment with either cladribine or pentostatin, and another 10% receive some benefit from these drugs, although there is no permanent cure for this disease. If the cancer cells return, the treatment may be repeated and should again result in remission, although the odds of success decline with repeated treatment.[36] Remission lengths vary significantly, from one year to more than twenty years. The median patient can expect a treatment-free interval of about ten years.

It does not seem to matter which drug a patient receives. A patient who is not successfully treated with one of these two drugs has a reduced chance of being successfully treated with the other. However, there are other options.

If a patient is resistant to either cladribine or pentostatin, then second-line therapy is pursued.

Monoclonal antibodies The most common treatment for cladribine-resistant disease is infusing monoclonal antibodies that destroy cancerous B cells. Rituximab is by far the most commonly used. Most patients receive one IV infusion over several hours each week for four to eight weeks. A 2003 publication found two partial and ten complete responses out of 15 patients with relapsed disease, for a total of 80% responding.[37] The median patient (including non-responders) did not require further treatment for more than three years. This eight-dose study had a higher response rate than a four-dose study at Scripps, which achieved only 25% response rate.[38] Rituximab has successfully induced a complete response in Hairy Cell-Variant.[39]

Rituximab's major side effect is serum sickness, commonly described as an "allergic reaction", which can be severe, especially on the first infusion. Serum sickness is primarily caused by the antibodies clumping during infusion and triggering the complement cascade. Although most patients find that side effects are adequately controlled by anti-allergy drugs, some severe, and even fatal, reactions have occurred. Consequently, the first dose is always given in a hospital setting, although subsequent infusions may be given in a physician's office. Remissions are usually shorter than with the preferred first-line drugs, but hematologic remissions of several years' duration are not uncommon.

Other B cell-destroying monoclonal antibodies such as Alemtuzumab, Ibritumomab tiuxetan and I-131 Tositumomab may be considered for refractory cases.

Interferon-alpha Interferon-alpha is an immune system hormone that is very helpful to a relatively small number of patients, and somewhat helpful to most patients. In about 65% of patients,[40] the drug helps stabilize the disease or produce a slow, minor improvement for a partial response.[41]

The typical dosing schedule injects at least 3 million units of Interferon-alpha (not pegylated versions) three times a week, although the original protocol began with six months of daily injections.

Some patients tolerate IFN-alpha very well after the first couple of weeks, while others find that its characteristic flu-like symptoms persist. About 10% of patients develop a level of depression. It is possible that, by maintaining a steadier level of the hormone in the body, that daily injections might cause fewer side effects in selected patients. Drinking at least two liters of water each day, while avoiding caffeine and alcohol, can reduce many of the side effects.

A drop in blood counts is usually seen during the first one to two months of treatment. Most patients find that their blood counts get worse for a few weeks immediately after starting treatment, although some patients find their blood counts begin to improve within just two weeks.[42]

It typically takes six months to figure out whether this therapy is useful. Common criteria for treatment success include:

If it is well tolerated, patients usually take the hormone for 12 to 18 months. An attempt may be made then to end the treatment, but most patients discover that they need to continue taking the drug for it to be successful. These patients often continue taking this drug indefinitely, until either the disease becomes resistant to this hormone, or the body produces an immune system response that limits the drug's ability to function. A few patients are able to achieve a sustained clinical remission after taking this drug for six months to one year. This may be more likely when IFN-alpha has been initiated shortly after another therapy. Interferon-alpha is considered the drug of choice for pregnant women with active HCL, although it carries some risks, such as the potential for decreased blood flow to the placenta.

Interferon-alpha works by sensitizing the hairy cells to the killing effect of the immune system hormone TNF-alpha, whose production it promotes.[43] IFN-alpha works best on classic hairy cells that are not protectively adhered to vitronectin or fibronectin, which suggests that patients who encounter less fibrous tissue in their bone marrow biopsies may be more likely to respond to Interferon-alpha therapy. It also explains why non-adhered hairy cells, such as those in the bloodstream, disappear during IFN-alpha treatment well before reductions are seen in adhered hairy cells, such as those in the bone marrow and spleen.[43]

Splenectomy can produce long-term remissions in patients whose spleens seem to be heavily involved, but its success rate is noticeably lower than cladribine or pentostatin. Splenectomies are also performed for patients whose persistently enlarged spleens cause significant discomfort or in patients whose persistently low platelet counts suggest Idiopathic thrombocytopenic purpura.

Bone marrow transplants are usually shunned in this highly treatable disease because of the inherent risks in the procedure. They may be considered for refractory cases in younger, otherwise healthy individuals. "Mini-transplants" are possible.

Patients with anemia or thrombocytopenia may also receive red blood cells and platelets through blood transfusions. Blood transfusions are always irradiated to remove white blood cells and thereby reduce the risk of graft-versus-host disease. Patients may also receive a hormone to stimulate production of red blood cells. These treatments may be medically necessary, but do not kill the hairy cells.

Patients with low neutrophil counts may be given filgrastim or a similar hormone to stimulate production of white blood cells. However, a 1999 study indicates that routine administration of this expensive injected drug has no practical value for HCL patients after cladribine administration.[44] In this study, patients who received filgrastim were just as likely to experience a high fever and to be admitted to the hospital as those who did not, even though the drug artificially inflated their white blood cell counts. This study leaves open the possibility that filgrastim may still be appropriate for patients who have symptoms of infection, or at times other than shortly after cladribine treatment.

Although hairy cells are technically long-lived, instead of rapidly dividing, some late-stage patients are treated with broad-spectrum chemotherapy agents such as methotrexate that are effective at killing rapidly dividing cells. This is not typically attempted unless all other options have been exhausted and it is typically unsuccessful.

More than 95% of new patients are treated well or at least adequately by cladribine or pentostatin.[45] A majority of new patients can expect a disease-free remission time span of about ten years, or sometimes much longer after taking one of these drugs just once. If re-treatment is necessary in the future, the drugs are normally effective again, although the average length of remission is somewhat shorter in subsequent treatments.

As with B-cell chronic lymphocytic leukemia, mutations in the IGHV on hairy cells are associated with better responses to initial treatments and with prolonged survival.[46]

How soon after treatment a patient feels "normal" again depends on several factors, including:

With appropriate treatment, the overall projected lifespan for patients is normal or near-normal. In all patients, the first two years after diagnosis have the highest risk for fatal outcome; generally, surviving five years predicts good control of the disease. After five years' clinical remission, patients in the United states with normal blood counts can often qualify for private life insurance with some US companies.[47]

Accurately measuring survival for patients with the variant form of the disease (HCL-V) is complicated by the relatively high median age (70 years old) at diagnosis. However, HCL-V patients routinely survive for more than 10 years, and younger patients can likely expect a long life.

Worldwide, approximately 300 HCL patients per year are expected to die.[48] Some of these patients were diagnosed with HCL due to a serious illness that prevented them from receiving initial treatment in time; many others died after living a normal lifespan and experiencing years of good control of the disease. Perhaps as many as five out of six HCL patients die from some other cause.[original research?]

Despite decade-long remissions and years of living very normal lives after treatment, hairy cell leukemia is officially considered an incurable disease. While survivors of solid tumors are commonly declared to be permanently cured after two, three, or five years, people who have hairy cell leukemia are never considered 'cured'. Relapses of HCL have happened even after more than twenty years of continuous remission. Patients will require lifelong monitoring and should be aware that the disease can recur even after decades of good health.

People in remission need regular follow-up examinations after their treatment is over. Most physicians insist on seeing patients at least once a year for the rest of the patient's life, and getting blood counts about twice a year. Regular follow-up care ensures that patients are carefully monitored, any changes in health are discussed, and new or recurrent cancer can be detected and treated as soon as possible. Between regularly scheduled appointments, people who have hairy cell leukemia should report any health problems, especially viral or bacterial infections, as soon as they appear.

HCL patients are also at a slightly higher than average risk for developing a second kind of cancer, such as colon cancer or lung cancer, at some point during their lives (including before their HCL diagnosis). This appears to relate best to the number of hairy cells, and not to different forms of treatment.[49] On average, patients might reasonably expect to have as much as double the risk of developing another cancer, with a peak about two years after HCL diagnosis and falling steadily after that, assuming that the HCL was successfully treated. Aggressive surveillance and prevention efforts are generally warranted, although the lifetime odds of developing a second cancer after HCL diagnosis are still less than 50%.

There is also a higher risk of developing an autoimmune disease.[13] Autoimmune diseases may also go into remission after treatment of HCL.[13]

Because the cause is unknown, no effective preventive measures can be taken.

Because the disease is rare, routine screening is not cost-effective.

This disease is rare, with fewer than 1 in 10,000 people being diagnosed with HCL during their lives. Men are four to five times more likely to develop hairy cell leukemia than women.[50] In the United States, the annual incidence is approximately 3 cases per 1,000,000 men each year, and 0.6 cases per 1,000,000 women each year.[13]

Most patients are white males over the age of 50,[13] although it has been diagnosed in at least one teenager.[51] It is less common in people of African and Asian descent compared to people of European descent.

It does not appear to be hereditary, although occasional familial cases that suggest a predisposition have been reported,[52] usually showing a common Human Leukocyte Antigen (HLA) type.[13]

The Hairy Cell Leukemia Consortium was founded in 2008 to address researchers' concerns about the long-term future of research on the disease.[53] Partly because existing treatments are so successful, the field has attracted very few new researchers.

In 2013 the Hairy Cell Leukemia Foundation was created when the Hairy Cell Leukemia Consortium and the Hairy Cell Leukemia Research Foundation joined together. The HCLF is dedicated to improving outcomes for patients by advancing research into the causes and treatment of hairy cell leukemia, as well as by providing educational resources and comfort to all those affected by hairy cell leukemia.[54]

Three immunotoxin drugs have been studied in patients at the NIHNational Cancer Institute in the U.S.: BL22,[55]HA22[56] and LMB-2.[57] All of these protein-based drugs combine part of an anti-B cell antibody with a bacterial toxin to kill the cells on internalization. BL22 and HA22 attack a common protein called CD22, which is present on hairy cells and healthy B cells. LMB-2 attacks a protein called CD25, which is not present in HCL-variant, so LMB-2 is only useful for patients with HCL-classic or the Japanese variant. HA-22, now renamed moxetumab pasudotox, is being studied in patients with relapsed hairy cell leukemia at the National Cancer Institute in Bethesda, Maryland, MD Anderson Cancer Center in Houston, Texas, and Ohio State University in Columbus, Ohio. Other sites for the study are expected to start accepting patients in late 2014, including The Royal Marsden Hospital in London, England.[58]

Other clinical trials[59] are studying the effectiveness of cladribine followed by rituximab in eliminating residual hairy cells that remain after treatment by cladribine or pentostatin. It is not currently known if the elimination of such residual cells will result in more durable remissions.

BRAF mutation has been frequently detected in HCL (Tiacci et al. NEJM 2011) and some patients may respond to Vemurafenib

The major remaining research questions are identifying the cause of HCL and determining what prevents hairy cells from maturing normally.[60]

Excerpt from:
Hairy cell leukemia - Wikipedia

Venture capitalists are betting big on regenerative medicine, but it’s … – Quartz

Until the myth of the fountain of youth proves true, regenerative medicine is the best hope weve got for fixing failed body parts and, as a result, living longer. Scientists wont be able to bottle forever. They are, however, working on engineering human cells, tissues, and organs that can repair themselves.

Basically, theyre trying to heal body parts using cells or tissue grown from stem cells, and by prompting regeneration with biologically active drugs that would essentially restart parts by forcing new growth, among other approaches. But its still a speculative venture, say Goldman Sachs analysts in an April 4 report on venture capital going into this novel frontier.

Perfecting processes for regenerating body parts is no mean feat, technically speaking. Plus, there are ethical questions to resolve and regulatory hurdles to overcome. In other words, itll take a while before new parts are available.

Nonetheless, investors are interested in the field, and especially in companies working with stem cells. Goldman analysts believe regenerative medicine is attractive because of its vast potential to eventually cure common and rare diseases in almost any tissue or organ, including the heart, liver, and lungs.

So, moneys going to regenerative medicine, at a rate of hundreds of millions of dollars annually. In 2010, the field attracted about $200 million in venture capital and in 2016, that figure had quadrupled. Stem cell technology attracts the vast majority of investment; $700 million of the $800 million dedicated to regenerative medicine in 2016 went to stem cell projects.

But analysts noted that the number of deals hasnt increased accordingly. Between 2010 and 2016 deals remained in a range of 30 to 40 while investment rose pretty steadily. This suggests that a few companies attracted larger investments per deal over time from venture capital firms.

Companies partnered with science giantslike BlueRock Therapeutics, which works with stem cell pioneer and Nobel laureate Shinya Yamanaka of Kyoto Universityget the largest investments and valuations, according to Goldman Sachs.

Analysts also remarked on Unity Biotechnology, which is developing a technique to eliminate senescent cellsor expiring cellsto increase longevity and maintain youthfulness, and has been shown to work in mice. Senescence is like a biological emergency brake cells use to stop dividing and multiplying out of control. But after the brakes been pulled, the senescent cells remain and accumulate, secreting inflammatory molecules that harm neighboring cells and tissues. Selectively removing them could keep people younger, healthier longer, according to the company.

Scientists seek funding from public sources too, of course. At the University of Washingtons Institute for Stem Cell and Regenerative Medicine, for example, researchers are manipulating stem cells to heal and restore the function in hearts, eyes, kidneys and other tissues, according to Charles Murray, the institutes interim director. In an April 9 editorial in the Seattle Times, he writes, This year, we also seek a first-time investment from our state legislature.

See the article here:
Venture capitalists are betting big on regenerative medicine, but it's ... - Quartz

The Incredible True Story of Henrietta Lacks the Most Important Woman in Modern Medicine – PEOPLE.com

Henrietta Lacks was just 30 years old when she discovered a lump on her cervix while in her bathtub at home.

A private-care doctor referred her to Johns Hopkins Hospital for further testing and she was diagnosed with cancer in January 1951. Lacks, the wife of a steelworker and a mother of five, was treated with radiation and sent home, but she was hospitalized the following August. She died at the age of 31 two months later.

But thats not where her story ends.

Without her knowledge or permission, doctors harvested samples of Lacks cervical tissue during her treatments and discovered her cancerous cells were not like any other theyd seen they were able to duplicate in labs and stay alive. This meant that the same sample of tissue could be tested multiple times for research, making her cell line immortal.

Research using Lacks cells helped spur numerous medical breakthroughs, include vaccines, cancer treatments and in vitro fertilization. But, for decades, her family was kept in the dark about her second life and were never compensated for her contributions.

Now, Oprah Winfrey is executive-producing and starring in anHBO movie adaptation of The Immortal Life of Henrietta Lacks the New York Times best seller by Rebecca Skloot that detailed how Lacks cells came to be known as the HeLa line, and how its existence has impacted the family she left behind.

They did what theyd never had another human cell do duplicate itself and then duplicate itself and then duplicate itself, Winfrey, who plays Lacks daughter Deborah in the movie, tells PEOPLE during the latest edition of The Jess Cagle Interview, excerpted in this weeks issue. (You can watch a video clip of it above.) Thats why its called the Immortal Life of Henrietta Lacks, because her cells even now as we speak are still replicating somewhere in some tube.

HeLa cells have contributed to medical advancements like the polio vaccine and have been used in gene mapping and AIDS and cancer research. And although Lacks died in 1951, her family didnt know that her cells were still alive in labs all over the country. That all changed in 1973, when doctors requested blood samples from them after HeLa inadvertently contaminated other samples.

Her family didnt know that anyone had taken her cells until much later on. Once they discovered it, trying to figure out how it all happened and how it unraveled and multi-millions of dollars, now billions of dollars, have been made off of the cells is the story of the Immortal Life of Henrietta Lacks, Winfrey says during the interview, which took place at The London West Hollywood in Beverly Hills.

The movie, airingApril 22, explores the familys hardships after finding out about the existence of the cells and their thwarted attempts to gather more information.

And though Skloot played by Rose Byrne in the movie originally set out to tell Lacks tale, the authorquickly realized the story went far beyond the woman behind the HeLa cells when she talked to Lacks daughter Deborah for the first time in 1999.

To me, it was not only about the woman, but what that doesto a family, Skloot tells PEOPLE. Deborah and I were both driven by this same obsessive passion to just answer these questions: Who was she? What happened? What can be done to make it so it doesnt happen again?

Although Deborah and Skloot shared this common goal, it took years for the second-youngest Lacks child to trust her. The family had gone through years of alleged mistreatment from medical professionals and were burned by people who had tried taking advantage of their connection to the famous HeLa cells. Skloot had to overcome these insecurities and show Deborah she could be trusted with her mothers story.

For me, the process of winning her trust was about figuring out why she was afraid, she says. I knew something happened to her that made her scared of me. It was definitely like the way you see it in the movie where we would go forward and good things would happen and she would panic and push me away. Usually it was because something happened related to her traumatic experiences and she would get scared and really challenge me.

Theircontentious relationship continued as Deborahs older brothers repeatedly tried to stop her from talking to Skloot, and tensions boiled over one day in a hotel room when Deborah, frightened and defensive, pushed Skloot against a wall. Still, the twocontinued to work together, eventually establishing a trust and friendship that led them to discover more about the mother Deborah never got to know.

Deborah died in 2009 before the book was published, but she did get to see her mother for the first time thanks to her work with the author.In 2001, Skloot, Deborah and her brother Zakariyya got the chance to visit Johns Hopkins and see the HeLa cells.

It was one of the most incredible and powerful moments of my life, Skloot says. That was the closest thing theyd ever seen to their mother being alive since they have no memory of her. It was beautiful for them to be in the presence of her in a way that felt the closest to her being alive. She knew that that wasnt her mother obviously, but it was like being able to have closure in a really beautiful way.

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The Incredible True Story of Henrietta Lacks the Most Important Woman in Modern Medicine - PEOPLE.com

Two new Series A rounds inject $72M into regenerative medicine and NASH – MedCity News


MedCity News
Two new Series A rounds inject $72M into regenerative medicine and NASH
MedCity News
Frequency is built around its so-called Progenitor Cell Activation (PCA) platform developed by Robert Langer and Jeffrey Karp from MIT and Harvard Medical School. Progenitor cells are slightly more specialized than stem cells. And while they typically ...
Frequency Therapeutics Announces $32 Million Series A Financing to Support Clinical Development of a First-in-Class ...Business Wire (press release)

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Two new Series A rounds inject $72M into regenerative medicine and NASH - MedCity News

James Rothman appointed Sterling Professor of Cell Biology – Yale News

James E. Rothman, newly appointed as a Sterling Professor of Cell Biology, is one of the world's most distinguished biochemists and cell biologists. For his work on how molecular messages are transmitted inside and outside of human cells, he was awarded a Nobel Prize in 2013.

A Sterling Professorship is one of the universitys highest faculty honors.

Rothman helped reveal the mechanism that allows cellular compartments called vesicles to transmit information both in the interior of the cell and to the surrounding environment. The fusion of vesicles and cellular membranes, a process called exocytosis, is basic to life and occurs in organisms as diverse as yeast and humans. Exocytosis underlies physiological functions ranging from the secretion of insulin to the regulation of the brain neurotransmitters responsible for movement, perception, memory, and mood.

Rothmans current research concerns the biophysics of membrane fusion and its regulation in exocytosis; the dynamics of the Golgi apparatus at super-resolution; and the use of bio-inspired design in nanotechnology.

After graduating from Yale College with a degree in physics, Rothman earned a Ph.D. in biological chemistry from Harvard Medical School. He conducted postdoctoral research at the Massachusetts Institute of Technology before moving to the Stanford School of Medicine as an assistant professor. He continued his research at Princeton University, where he became the founding chair of the Department of Cellular Biochemistry and Biophysics at Memorial Sloan-Kettering Cancer Center and vice chair of the Sloan-Kettering Institute. Prior to coming to Yale in 2008, Rothman served on the faculty of Columbia Universitys College of Physicians and Surgeons, where he was a professor in the Department of Physiology and Biophysics, the Clyde and Helen Wu Professor of Chemical Biology, and director of the Columbia Genome Center.

Rothman serves as chair of the Yale School of Medicines Department of Cell Biology and as director of the Nanobiology Institute on Yales West Campus.

He has received numerous awards and honors in recognition of his work on vesicle trafficking and membrane fusion, including the King Faisal International Prize for Science, the Gairdner Foundation International Award, the Lounsbery Award of the National Academy of Sciences, the Heineken Foundation Prize of the Netherlands Academy of Sciences, the Louisa Gross Horwitz Prize of Columbia University, the Lasker Basic Science Award, the Kavli Prize in Neuroscience, the Massry Prize, and the E.B. Wilson Medal. He is a member of the National Academy of Sciences and its Institute of Medicine, and is a fellow of the American Academy of Arts and Sciences.

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James Rothman appointed Sterling Professor of Cell Biology - Yale News

Brain cell therapy offers hope for Parkinson’s patients – CBS News

Scientists from Sweden say they have made significant progress in the search for a new treatment for Parkinsons disease.

Though the research, published in Nature Biotechnology, is still preliminary and the therapy not yet ready to be tested in humans, experts say it could one day help the millions of people living with the neurodegenerative disease.

Researchers from the Karolinska Institute tested whether certain brain cells could be manipulated to take on the role of those destroyed by Parkinsons.

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They first showed in laboratory experiments that it was possible to convert non-neural human brain cells called astrocytes into dopamine neurons, which degenerate and die in the brains of people suffering from Parkinsons disease.

These are two specialized cells that do not spontaneously convert into one another, study author Ernest Arenas, a professor at Karolinska Institutes Department of medical biochemistry and biophysics, told CBS News. However, when we used diverse chemicals and genes important for the development of immature brain cells into functional dopamine neurons, we found that it was possible to convert astrocytes into dopamine neurons.

The researchers then tested whether this could be done in mice with Parkinsons and if the therapy would improve their condition.

After two weeks, they reported that astrocytes in the brains of the mice started to become dopamine neurons. At five weeks, the mice recovered some of their motor functions such as posture, motility and walking pattern.

Current treatments for Parkinsons only address symptoms, not the cause of the disease itself.

While much more research is needed before the treatment can be tested in humans, Arenas says it could one day lead to an approach to change the course of disease and halt or even reverse motor deficits in Parkinsons disease patients.

Aside from being in early stages, the research is limited in several ways, the study authors say.

First, Arenas notes that although dopamine neurons are the main cell type affected in Parkinsons disease -- and those responsible for the characteristic motor symptoms -- other cell types are affected, particularly as the disease progresses. Therefore, additional strategies to treat these other cell types will be needed in the future.

Additionally, this type of therapy would involve surgery, and therefore could be riskier compared to other treatments on the market. However, with people living longer in most societies, more severe forms of disease are currently being seen, Arenas said, and people are suffering longer.

We thus think that cell replacement therapies, because of its potential to change the course of disease, may become the method of choice in the future, he said.

The authors say now that they know the treatment technique is possible, future research will concentrate on making it safer and developing it into a method that could be applied in a clinical setting.

Our goal and hope is that all these studies will lead to the development of a safe and efficient cell replacement therapy for Parkinsons disease in which no cell transplantation or immunosuppression is necessary, Arenas said.

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Brain cell therapy offers hope for Parkinson's patients - CBS News

Taking Cell Therapy one Step Further with this Boost Reagent – Labiotech.eu (blog)

Cell therapy is revolutionizing medicine, heres how the latest technology can help overcome the major challenges stopping it from taking over the market.

Offering unprecedented possibilities to treat some of the most challenging diseases, cell therapy is stealing the show in the biotech space. Strimvelis, the first hematopoietic stem cell (HSC) gene therapy is already treating rare genetic diseases. In less than a year, CAR-T therapy is expected to hit the market and revolutionize the treatment of cancer. And in the not-so-far future, cell therapy could even eradicate HIV or put an end to diabetes, which is reaching epidemic proportions in Western countries.

The first cell therapies have already been on the market for a few years, and analysts are confident that the numbers will quickly grow over the years. The stem cell therapy market alone is expected to hit 57Bn ($61Bn) by 2022, and the upcoming CAR-T technology will reach an impressive 8Bn ($8.5Bn) in the next decade.

Although the potential is definitely there, researchers are still looking for ways of making these therapies cheaper, safer and more effective. Currently, not all patients are suited to receive cell therapy due to scientific or economic challenges. The advent of allogeneic therapies is addressing the financial obstacles, but what about efficiency?

One of the key elements to building a successful cell therapy are viral vectors, which are used to deliver the necessary DNA sequences to engineer the cells. Lentiviral vectors are a common choice because they have a rather larger capacity and enable long-lasting genetic expression.

They are specially researched for ex-vivo treatment of hematopoietic stem cells and primary T-cells. The percentage of cells that can be reached, however, often remains low, and the number of gene copy numbers per cell can be extremely variable.

Finding a solution to this challenge is unfortunately not as simple as increasing the virus load. Cells that carry a surplus of copies integrated into their DNA are more prone to mutations that affect their survival and put the safety of the patient in danger. This is an essential factor taken into account during the regulatory phase to determine whether a therapy can make it to the market or not.

How can we then improve the efficacy of transduction without affecting the health of the cells and the safety of the therapy? In the lab, researchers often use enhancers such as polybrene, a polymer that can increase the efficacy of transduction of viral DNA. However, this substance is not applicable in a clinical context because of its heightened cell toxicity.

To overcome these challenges, scientists at SIRION Biotech got down to work and screened for compounds that could improve the fusion of the viral and cell membranes. The result was a technology with the potential to solve a major problem in the development of cell therapies, with DNA delivery reaching an impressive 80% of hematopoietic stem cells while keeping the copy numbers down to the ideal value of 3 to 5 per cell.

This technology, called LentiBOOST, works its magic simply by adding a non-toxic polymer to the mixture during transduction. It has already been accepted as an element of clinical trials from phase I to phase III and its possibilities seem unlimited. One of SIRIONs partners, the Heinrich Pette Institute in Hamburg, is studying the potential of LentiBOOST to improve transduction in a therapy intended to actively remove HIV from infected blood cells and induce long-lasting resistance against the virus.

With applications ranging from cancer to infectious disease, cell therapy is definitely going to change medicine. Technology like LentiBOOST is helping these amazing developments materialize with a boost to both their efficacy and safety.

You can find more information on LentiBOOST at SIRION Biotechs website!

Images from Montri Thipsorn, vchal /Shutterstock; SIRION Biotech

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Taking Cell Therapy one Step Further with this Boost Reagent - Labiotech.eu (blog)

DCGI approves Regenerative Medical’s stem cell therapy for cartilage defects – Livemint

Mumbai: Regenerative Medical Services Pvt. Ltd on Wednesday said that the Drug Controller General of India (DCGI) recently approved its stem cell-based therapy to treat cartilage defects.

Chondron, its cartilage repair procedure, uses the bodys own cartilage cells that are cultured, multiplied and implanted into the patients damaged joint leading to new cartilage regeneration and avoiding the need for early joint replacement. This is the first stem cell-therapy product to be approved in India.

We are creating new age cartilage regeneration procedure which optimizes the chances of healing due to the use of the bodys own cells. We will tie up with hospitals to promote it; we have received interest from around 200 hospitals, chief executive officer and managing director Yash Sanghavi said.

The company has capacity to culture 1,000-1,200 patient samples annually, which it plans to enhance to 10,000-12,000 samples in next three years, chief scientific officer Satyen Sanghavi, said.

The Mumbai-based company, started in 2009, has invested around Rs70-75 crore on development of Chondron and conducted clinical trials on 350 patients. It is looking to raise funds for capacity expansion and marketing of the cell therapy.

We are looking to raise Rs40-50 crore through equity dilution and have already appointed bankers, Sanghavi said. The treatment, he said, is likely to cost around Rs2 lakh, which is almost the same or slightly lower than the price of a knee replacement surgery.

First Published: Wed, Apr 12 2017. 09 11 PM IST

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DCGI approves Regenerative Medical's stem cell therapy for cartilage defects - Livemint

Fundraising appeal for stem cell treatment after chickenpox triggers … – News Shopper

A desperate father has launched a fundraising bid to treat his sonafter he was diagnosed with a debilitating central nervous system disease.

Tiago Gouveia was diagnosed with Spinal Cerebellar Ataxia Type Seven (SCA7) after chickenpox triggered the genetic condition, inherited from father Marvino.

The four-year-old can no longer walk unaided and his weight has dropped to just 1.7 stones - 11kg - since last May - half of what he should normally weigh for his age.

He has also developed kidney disease as a result of his illness and could go blind, lose his ability to speak and no longer be able to swallow if not treated.

Dad Marvino, 40, who lives in Malvern Road, Orpington, is now hoping to raise 30,000 to fund stem cell treatment in Bangkok, Thailand, which could cure Tiago.

He said: "He was born well, and he was a normal child growing up until the age of two-and-a-half.

"In May 2015, he was with his cousin who had chickenpox, and it triggered the disease.

"It's a genetic condition, and I carry the gene - my mum, sister and niece all have it.

"After six to seven months, Tiago stopped walking and got a lot more wobbly before it came to a point where he couldn't walk anymore.

"He's lost lots of weight and for now his sight is okay, but it will get worse.

"He was vomiting every day until he got a gastrostomy on April 4, and we're hoping that will stop it - he had been fed through a tube since November but it was making him sick.

"He developed nephrosis, which affects his kidneys, so now he's on steroids as well as seven or eight other types of medication.

"It came to the point where we said we can't wait to fix him, so we decided to start the fundraising page for stem cell treatment."

Tiago has inherited the condition from finance worker Marvino, whose mother, sister and niece also have the genetic disorder.

His Geneva-based sister Canisia Brunier, 52, her daughter Melissa, 21, and Marvino's mother Latifa Goveia, 71, who lives in his native Portugal, all suffer from SCA7.

Marvino added: "He's got a bad gene, and because he's young and male the disease is developing much more quickly.

"He weighs 11kg and he should be double that, he's very skinny and you can see all his bones.

"Sometimes he's in a good mood but the medication gives him really bad moods.

"I don't have words to describe it, it's just too much."

Marvino and full-time carer wife Rosa Gouveia, 38, are also parents to Andre, 11, who does not have SCA7.

The family are now hoping to raise enough money for Tiago to undertake crucial stem cell treatment.

They have already raised 7,200 on JustGiving but need more.

Marvino said: "We're hoping we can get this money to help him, it's been very tough seeing him suffer like this - he's always sick.

"The stem cell treatment could help a lot or maybe even cure him and the doctor says he has a very good chance of improving.

"He's getting worse every day so need to do it soon.

"We've had a lot of support from our friends and family and we're really happy with how much we've raised, but we're still trying to spread the word."

The fundraising page is here

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Fundraising appeal for stem cell treatment after chickenpox triggers ... - News Shopper

Human Embryonic Stem Cells Market Size Worth $1.06 Billion by … – Yahoo Finance

SAN FRANCISCO, April 11, 2017 /PRNewswire/ --

The global human embryonic stem cells (hESCs) marketis anticipated to reach USD 1.06 billion by 2025, according to a new report by Grand View Research, Inc. Application of hESCs as a promising donor source for cellular transplantation therapies is anticipated to bolster progress through to 2025. hESCs technology tends to be useful for tissue engineering in humans due to high histocompatibility between host and graft.

(Logo: http://photos.prnewswire.com/prnh/20150105/723757 )

Maintenance of developmental potential for contribution of derivatives of all three germ layers is an important feature of these cells. This ability remains consistent even after clonal derivation or prolonged undifferentiated proliferation, thus pronouncing its accelerated uptake.

In addition, these are capable in expressing high level of alkaline phosphatase, key transcription factors, and telomerase. These factors are found to be of great importance in the maintenance of the inner cellular mass pluripotency.

Furthermore, hESCs can be easily differentiated into defined neurons, neural lineages, oligodendrocytes, and astrocytes. Aforementioned characteristic makes it useful in studying the sequence of events that take place during early neurodevelopment.

However, use of stem cells derived from viable embryos is fraught with ethical issues, prompting scientists to explore other methods to generate ESCs. The other methods include derivation of embryonic germ cells, stem cells from dead embryos, and other techniques.

Browse full research report with TOC on "Human Embryonic Stem Cells (hESC) Market Analysis By Application (Regenerative Medicines, Stem Cell Biology Research, Tissue Engineering, Toxicology Testing), By Country (U.S., UK, Germany, Japan, China), And Segment Forecasts, 2014 - 2025" at: http://www.grandviewresearch.com/industry-analysis/human-embryonic-stem-cell-market

Further key findings from the report suggest:

Browse related reports by Grand View Research:

Grand View Research has segmented the human embryonic stem cells market on the basis of application and region:

Read Our Blog: http://www.grandviewresearch.com/blogs/healthcare

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. Thecompany provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

Contact: Sherry James Corporate Sales Specialist, USA Grand View Research, Inc Phone: 1-415-349-0058 Toll Free: 1-888-202-9519 Email: sales@grandviewresearch.com

Web: http://www.grandviewresearch.com

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Human Embryonic Stem Cells Market Size Worth $1.06 Billion by ... - Yahoo Finance