Stem Cell Clinic

Antibody cocktail given to Trump is controversial, and not only because its still under trial – ThePrint

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New Delhi: US President Donald Trump was given an array of drugs to treat his Covid-19 symptoms. These included remdesivir, steroid dexamethasone, and an experimental cocktail of antibodies by biotech major Regeneron Pharmaceuticals.

While remdesivir and dexamethasone have been known to be used for mild and severe cases of Covid, the eight grams of experimental cocktail Trump was given generated controversy partly because it is still under trial, but also because it uses a method of research that has stirred Trumps voter base in the past: embryonic stem cell research.

In a statement on the research in April, the company said: Regeneron uses a wide variety of research tools and technologies to help discover and develop new therapeutics. Stem cells are one such tool. It added that there are limited research efforts employinghuman embryonic stem cells.

Trump has repeatedly identified himself as pro-life, a belief that nothing should harm life once it has been conceived. This is in line with the conservatives, who are often anti-abortion because of their Christian beliefs and make up a chunk of the Republican vote. In 2019, Trump even clamped down on the use of foetal tissue in scientific research.

In March this year, the Washington Post reported that a scientist was forced to abandon his research into a coronavirus treatment because of Trumps foetal tissue laws.

Also read:Trump leaves hospital but White House to restrict access to him during recovery

Embryonic stem cell research involves using cells at the embryo stage, when the human egg has been fertilised by sperm. The fertilised egg is referred to as an embryo till the 9th week, after which it is called a foetus.

Embryonic stem cells are sought after in scientific research because they can develop into all cell types of the body. While embryonic cells from abortions are commonly used, Regeneron clarified that it uses embryos that have been created solely through in vitro fertilization.

In 2001, the George Bush administration restricted federal funding for embryonic stem cell research. Bush, a conservative and Christian, said at the time, At its core, this issue forces us to confront fundamental questions about the beginnings of life and the ends of science.

This was changed only after Barack Obama came to power in 2008.

After Trump took the Oval Office in 2016, a ban or restriction on the use of embryonic and foetal tissue research was always on the cards. In 2019, the government officially imposed restrictions on the federal funding of research requiring foetal tissue.

According to the new rules, scientists must detail why exactly they require fetal tissue and how it will be obtained.

In its statement, Regeneron said it uses embryonic cells that are approved for research use by the National Institutes of Health and adheres to federal and state laws and regulations.

The cocktail given to Trump includes a mix of two potent antibodies directed against a spike protein found on the novel coronavirus surface. The therapy is still under trial. Regeneron released preliminary results last month saying it was safe, reduces viral load, and eases symptoms.

While recovering this week, Trump put out a spate of Tweets about the therapy. One of them said, PRO LIFE! VOTE!.

But Twitter users were quick to point out the hypocrisy.

Also read:Trump intends to be ready to debate Biden next week but will oppose a mute button

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Antibody cocktail given to Trump is controversial, and not only because its still under trial - ThePrint

Stem cell therapy for blood cancer patients at NIMS – The Hindu

In a big blessing for blood cancer patients requiring stem cell therapy, the State government has established a Centre for Stem Cell and Regenerative Medicine in the Nizams Institute of Medical Sciences (NIMS). The facility will particularly help those from the lower strata of the society who cannot afford corporate medical care.

The centre was inaugurated on Friday by Health Minister Eatala Rajender in the presence of NIMS Director K. Manohar and Superintendent N. Satyanarayana. The centre will provide a ray of hope to blood cancer patients from poor families, those covered under Aarogyashri scheme, requiring stem cell therapy as they would be treated at the centre free of cost, the Minister saidafter dedicating the stem cell and molecular lab as part of the centre to the people.

With the opening of the stem cell therapy centre, NIMS has grown into one of the major hospitals in the country, Mr Rajender stated samples of blood cancer patients which were sent to Delhi for diagnosis earlier can now be done here itself. The success rate of NIMS in stem cell therapy among kidney and heart transplantation patients was very high, he said, but some services were stopped due to rise in COVID-19 cases. However, all services would be resumed within a week with the COVID spread now under control.

Stating that living with COVID-19 would be a new norm as the society was doing with dengue, viral fever, swine flu and malaria, the Minister said and asserted that as per ICMR statistics, about 40 lakh people in Telangana had developed antibodies to COVID and the fleecing of patients families by corporate hospitals in the name of plasma therapy and some costly injections was wrong.

Mr Rajender admitted that COVID treatment in NIMS had impacted the treatment of other patients, particularly those coming in emergency health conditions, and made it clear that outpatient services would be scaled up soon with OP and Critical Care blocks being set up with an investment of 250 crore. Chief Minister K. Chandrasekhar Rao would lay the foundation stone for the new blocks soon to scale up the outpatient services from 2,500 a day in the past to 5,000 a day.

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Stem cell therapy for blood cancer patients at NIMS - The Hindu

The Global Stem Cell Therapy Market Growth To 2023 Will Be Driven By Increasing Prevalence Of Chronic Diseases – Press Release – Digital Journal

"Global Stem Cell Therapy Market, Forecast Market Size, 2019 2023, $ Billion"

The Business Research Companys Global Stem Cell Therapy Market Report 2020-30: Covid 19 Growth And Change; Segments Covered: 1) By Type: Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy 2) By Cell Source: Adult Stem Cells, Induced Pluripotent Stem Cells, Embryonic Stem Cells 3) By Application: Musculoskeletal Disorders, Wounds and Injuries, Cancer, Autoimmune Disorders, Others 4) By End-User: Hospitals, Clinics

The global stem cell therapy market is expected to decline from $8.73 billion in 2019 to $8.62 billion in 2020 at a compound annual growth rate (CAGR) of -1.24%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The global stem cell therapy market is then expected to recover and reach $14.76 billion in 2023 at a CAGR of 19.62%.

The rising prevalence of chronic diseases contributed to the stem cell therapy market growth. Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases among people, thus driving the need for stem cell therapy. According to a United Nations article, by 2030, the proportion of global deaths due to chronic diseases is expected to increase to 70% of total deaths. The global burden of chronic diseases is expected to reach about 60%. The rising prevalence of chronic diseases is expected to drive the global stem cell therapy market growth.

Companies in the stem cell therapy market are increasingly investing in strategic partnerships. The strategic partnership is a mutually beneficial agreement between two companies that do not compete directly with each other. For instance, in September 2018, CRISPR Therapeutics, a biotechnology company that develops transformative medicine using the gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated for the development and commercialization of allogeneic stem cell therapies for diabetes treatment.

The high cost of stem cell therapy is expected to limit the growth of the stem cell therapy market. The pressure to contain costs and demonstrate value is widespread. Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding. In less wealthy countries, the lack of cost-effective therapies for chronic diseases has impacted the health conditions of the population and has led to a low average life expectancy. According to the DVCSTEM, the average cost of stem cell therapy in the USA is between $20,000 to $25,000, in Mexico, it is $33,000, in Central America, it is $30,000, and in Asia, it is $50,000, thus restraining the growth of the market.

The stem cell therapy market consists of the sales of stem cell therapy and related services by entities (organizations, sole traders, and partnerships) that provide stem cell therapy. Stem cell therapy, also known as regenerative medicine, promotes the repair response of a diseased patient, or a dysfunctional or injured tissue using stem cells or their derivatives.

Here Is A List Of Similar Reports By The Business Research Company:

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The Global Stem Cell Therapy Market Growth To 2023 Will Be Driven By Increasing Prevalence Of Chronic Diseases - Press Release - Digital Journal

Mesoblast hit by FDA rejection, request to run another trial – FierceBiotech

The FDA has issued (PDF) a complete response letter to Mesoblasts request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data.

Evidence of the FDAs concerns with Mesoblasts remestemcel-L filing emerged in August when the agency released a briefing document to inform a discussion of the application by the Oncologic Drugs Advisory Committee (ODAC). The FDA cited multiple perceived shortcomings of the filing, arguing for example that the ability of the mesenchymal stem cell therapy to reduce inflammation as measured by inflammatory biomarkers in humans receiving the product has not been demonstrated.

Despite the FDAs concerns, ODAC members voted nine to one that the data support the efficacy of remestemcel-L in children with steroid-resistant graft-versus-host disease. The positive ODAC vote sent shares in Mesoblast, which had been depressed by the briefing document, up 50%.

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However, the ODAC vote was advisory, and the FDA, in a rare but far from unprecedented action, has chosen to go against the recommendation of the committee. Shares in Mesoblast fell 37% in response to the rejection, sinking back to the low they hit in the wake of the briefing document.

Mesoblast said the FDA has recommended it runs at least one additional randomized clinical trial in adults or children with steroid-resistant graft-versus-host disease before refiling for approval. The recommendation suggests Mesoblast will need to expend time and money to get remestemcel-L to market. The phase 3 trial cited in the briefing document lasted almost three years.

However, Mesoblast is holding out hope that it can get remestemcel-L to some patients without the extra data requested by the FDA. In light of the unmet medical need, Mesoblast plans to request a Type A meeting with FDA to discuss the possibility of an accelerated approval. Mesoblast is hoping the FDA will agree to authorize remestemcel-L on the proviso that it runs a study post-approval.

If Mesoblast is to persuade the FDA to grant remestemcel-L accelerated approval, it may need to address some of the agencys other concerns. Mesoblast said the FDAs response letter identified the need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

The comment reflects sections of the briefing document in which the FDA said the quality attributes lack a demonstrated relationship to the clinical performance of specific [drug product] lots. In the absence of evidence of that relationship, the FDA said the attributes may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality.

In disclosing the response letter, Mesoblast said assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk.

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Mesoblast hit by FDA rejection, request to run another trial - FierceBiotech

First Man Cured of AIDS Dies From Cancer – The Keystone Newspaper

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By Dylan Adams News Editor

Timothy Ray Brown, the first known person to be cured of HIV, died on Sept. 29 at age 54 after battling cancer.

Timothy Ray Brown, a figurehead in the AIDS and HIV community, passed away surrounded by friends after a five-month battle with leukemia, stated Tim Hoeffgen, Browns partner.

Brown received a positive HIV diagnosis in 1995 while studying in Berlin.

In 2006, Brown was diagnosed with acute myeloid leukemia, which is a cancer that builds in the bone marrow and blood interfering with blood cell production. After bouts of infections from several rough rounds of chemotherapy, Browns leukemia came out of remission.

Due to leukemia in his bones, Brown required a stem cell transplant, a process that allows healthy stem cells to be introduced into a host to stimulate the immune system and healthy bone marrow growth. At the time, the survival rates for stem cell transplant were around fifty percent.

Doctors found a match to Browns genetic type, a donor with the CCR5 Delta 32 mutation, a protein that acts as a doorway to stop the HIV from infecting new cells. Three months after Brown stopped taking his HIV medication, doctors found he no longer had HIV in his blood.

After another round of stem cell treatment in February of 2008, Brown went through several near-death complications, almost going blind and becoming paralyzed but slowly recovering. His body was still successfully fighting off HIV.

In July 2012, the Timothy Ray Brown Foundation was created during the World AIDS Conference in Washington, DC. This foundation was built for Brown to show his support and work with medical institutions and scientists to develop a unifying cure and vaccination against HIV.

Brown would often donate large amounts of blood and tissue samples to researchers in the hope of progressing closer towards an HIV cure. According to his partner, Hoeffgen, Tims lifework was to tell his story about his HIV cure and become an ambassador of hope to those in need.

Doctors have since used Brown as a blueprint to work on a potential cure and vaccine for HIV. Most notably for the second person to ever be cured of HIV the London Patient, Adam Castillejo who went through similar stem cell transplants in 2019 before coming forward to the public.

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First Man Cured of AIDS Dies From Cancer - The Keystone Newspaper

Avrobio bags gene therapy to join Regenxbio and Sangamo in race – FierceBiotech

Avrobio has licensed a Hunter syndrome lentiviral gene therapy from the University of Manchester in the U.K. The deal positions Avrobio to join Regenxbio and Sangamo Therapeutics in the race to develop gene therapies for use in patients with the rare disorder.

Hunter syndrome, also known as mucopolysaccharidosis Type II, is driven by a mutation that limits a patients ability to break down sugar molecules generated as a byproduct of cell activity. The buildup of the molecules causes progressive damage to organs such as the brain, affecting the development of children with the lysosomal disorder.

Takedas approved drug Elaprase gives Hunter syndrome patients the enzyme they need to break the molecules down, but its inability to cross the blood-brain barrier renders it ineffective against the CNS manifestations of the disease.

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Avrobio has become the latest company to identify gene therapy as a potentially better way to treat Hunter syndrome. The biotech, which is active in other lysosomal disorders, has agreed to pay the University of Manchester $8 million upfront for the global rights to a stem cell gene therapy that is set to enter the clinic in the second half of next year.

Brian Bigger, Ph.D., a professor of cell and gene therapy at the U.K. university, developed the candidate and co-authored a paper about it in 2018. The paper describes work on a braintargeted hematopoietic stem cell gene therapy designed to give patients the lysosomal enzyme iduronate-2-sulfatase (IDS).

Avrobio will make the therapy, now called AVR-RD-05, by modifying a patients own hematopoietic stem cells with a transgene for IDS expression and a protein tag intended to improve stability of the enzyme. If AVR-RD-05 works as hoped, the cells will engraft in the bone marrow and make copies of themselves that also carry the transgene.

The differentiation of the cells into components of the immune system could enable AVR-RD-05 to cause a lasting, body-wide increase in the presence of the enzyme at the root of Hunter syndrome. Avrobio will fund a 9.1 million ($11.8 millon) investigator-sponsored phase 1/2 trial to assess whether the gene therapy performs as hoped. The biotech is also on the hook for up to $80 million in milestones.

Avrobio will face competition if it gets AVR-RD-05 all the way to market. Takeda is the incumbent, Regenxbio and Sangamo have gene therapies in the clinicalthough the latter has underwhelmed so farand Denali Therapeutics is developing an IDS enzyme designed to cross the blood-brain barrier.

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Avrobio bags gene therapy to join Regenxbio and Sangamo in race - FierceBiotech

FDA Grants Breakthrough Therapy Designation to CD123-Directed Antibody-Drug Conjugate – Targeted Oncology

The FDA has granted a Breakthrough Therapy designation to IMGN632 as treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasms (BPDCN), ImmunoGen, Inc., announced in a press release.

We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer, said Mark Enyedy, president and chief executive officer, ImmunoGen, in a statement. We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies.

IMGN632, a CD123-targeting antibody-drug conjugate (ADC), is in clinical development for the treatment of hematologic malignancies like BPDCN, acute myeloid leukemia (AML), and acute lymphocytic leukemia in clinical trials. The agent is under evaluation as monotherapy in patients with BPDCN and minimal residual disease (MRD)-positive AML after induction treatment, as well as in combination with venetoclax (Venclexta) plus azacitidine (Vidaza) in patients with relapsed/refractory AML.

BPDCN, a rare blood cancer, is known to have features associated with both leukemias and lymphomas, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This is an aggressive cancer that requires intense treatment regimens that are often followed by stem cell transplantation. This represents a patient population of unmet need, particularly those in the relapsed/refractory setting.

The phase 1/2 open-label, multicenter clinical trial of IMGN632 plus venetoclax and azacitidine is investigating the safety and efficacy, as well as assess the antileukemic activity of the combination in patients with relapsed assessed in frontline CD123-positive AML. The antileukemia activity of the monotherapy will also be assessed in patients with MRD-positive AML.

The primary end points of the study include safety and tolerability, preliminary antileukemia activity, and MRD levels. The study is currently recruiting and is exploring several different doses of the ADC. IMGN632 will be assessed in combination and monotherapy across multiple regimen arms. Arm A will assess azacitidine, arm B venetoclax, arm C azacitidine plus venetoclax, and arm D will evaluate IMGN632 monotherapy in patients with MRD+ AML.

For arms A through C, a phase 1b dose-escalation cohort in arms A through C will determine the recommended phase 2 dose, and a phase 2 dose-expansion phase will further evaluate each regimen in arms A through D to characterize the safety profile and assess the antileukemia activity. Arm D will open with a dose-expansion cohort, using the ADC monotherapy dose and schedule based on the findings from the initial phase 2 IMGN632-0801 study, and there will be no dose-escalation portion.

To be included in the trial, patients must be at least 18 years of age, have a confirmed AML diagnosis, and be deemed appropriate for this experimental therapy per the treating physician. Patients must have CD123-positive AML to be included in the study, and they were allowed to have received prior CD123-targeted therapies, as long as they have not received IMGN632. Patients had to have an ECOG performance status 1 and resolution of any prior treatment-related toxicities to either grade 1 or baseline.

Patients cannot have received any anticancer therapy within 14 days before administration of the study drug, prior IMGN632 therapy, a myeloproliferative neoplasm-related secondary AML, or active central nervous system AML. They are also ineligible if they have a history of sinusoidal obstruction syndrome/venous occlusive disease of the liver, myocardial infarction within 6 months of enrollment, or clinically relevant active infection, including known active hepatitis B or C, HIV infection, cytomegalovirus, or other infectious diseases that would make the patient inappropriate for enrollment to this study.

Reference

ImmunoGen announces FDA breakthrough therapy designation for IMGN632 in relapsed or refractory blastic plasmacytoid dendtritic cell neoplasm. News Release. ImmunoGen, Inc. October 5, 2020. Accessed October 5, 2020. https://bit.ly/3ljtSFt

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FDA Grants Breakthrough Therapy Designation to CD123-Directed Antibody-Drug Conjugate - Targeted Oncology