Research advances curative options for people with sickle cell

For nearly two decades, a bone marrow transplant has been the only known cure for sickle cell disease, an inherited blood disorder that can cause excruciating pain for those who have it. But very few patients have qualified for the grueling procedure. And they’re mainly children, who can better tolerate the high doses of chemotherapy needed to wipe out the bone marrow, which doctors then replace with matching donor stem cells from a sibling.

Today, researchers at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, are on a fast track to change that bleak outlook. They are working hard to expand options that not only treat sickle cell disease, but also cure it. From new transplant approaches to new genetic therapies, the treatments, these researchers say, could be game changers in the not-so-distant future.

“It’s an exciting time because people with sickle cell disease may one day have three more curative options to choose from, not just the traditional bone marrow transplant,” said Courtney Fitzhugh, M.D., who has had recent success with bone marrow transplantation in adults.

An investigator in the Laboratory of Early Sickle Mortality Prevention, part of NHLBI’s Cellular and Molecular Therapeutics Branch, Fitzhugh’s latest transplant regimen has been recruiting adults with sickle cell disease for a clinical study since 2017, and the results so far have been encouraging. Instead of completely replacing a patient’s bone marrow with that of their donor, Fitzhugh says it’s now possible to reverse sickle cell disease using a mixture of donor and patient cells. Eligible participants only need a relative, such as a parent or child, whose stem cells only partially match the patient’s. This change—from needing a full match— increases the patient’s chances of finding a suitable donor from 10% to 90%. Further, because this approach does not include high dose chemotherapy, patients with severe organ damage may be eligible for transplant.

Before receiving donor cells, participants will need to take a combination of medications to suppress only part of their immune system and reduce the risk of graft-versus-host-disease, a serious complication that occurs when donor cells recognize the patient’s healthy cells as foreign, then attack them. Fitzhugh will follow participants three months after the transplant to make sure this complication doesn’t occur. She also wants to ensure that the donor cells aren’t rejected and the disease hasn’t returned. Patients will also be followed for many years afterwards to evaluate efficacy of the procedure and to check for any long-term effects of the transplant on their organs.

Also in the works are a number of genetic therapies aimed at correcting the abnormal beta globin gene that results in rigid, sickled red blood cells that wreak havoc on the body, especially when the blood cells are exposed to low oxygen levels. Gene addition therapy, said John Tisdale, M.D., can restore the missing function of the faulty gene by adding a new gene to bone marrow stem cells harvested from the patient. The new gene—a normal version of the faulty gene—would then produce healthy red blood cells.

“We’ve been able to reduce frequent pain that lands patients in the hospital by using this gene addition therapeutic approach in combination with a conditioning treatment that creates space in the marrow,” said Tisdale, chief of NHLBI’s Cellular and Molecular Therapeutic Branch. “The reduction in pain has been remarkable, and this approach is working. It’s really exciting.”
Another newer curative therapy is gene editing, which researchers could use to reactivate fetal hemoglobin that is typically present during fetal life. When sickle cell disease develops, a misspelled adult hemoglobin is soon replaced after birth.

Investigators don’t yet know which therapeutic approach will reach patients first, but Traci Mondoro, Ph.D., chief of NHLBI’s Translational Blood Science and Resources Branch, said the groundwork is being laid to make sure whatever emerges is effective. Mondoro helps manage NIH’s Cure Sickle Cell initiative, which supports research into promising therapies like these so that they can be safely used in clinical research in the years to come. It also adds to existing efforts being funded by NHLBI, such as basic biology and pain research.

“Therapeutic approaches, such as gene therapy and gene editing, are still in the early stages,” said Mondoro. “While these approaches are not suitable for all, we are also working with a sense of urgency to research other treatment options for older or sicker patients.”

National Sickle Cell Awareness Month Series:

Sickle Cell Treatment Options for Pain Management are Growing

Genetics, diagnosis, treatment: NIH takes on sickle cell disease globally

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Additionally, OSHA’s data do not include comprehensive information on workplace exposure to COVID-19. For example, OSHA does not receive employer reports of all work-related hospitalizations related to COVID-19, as disease symptoms do not appear within the required reporting time frames. Employers may also face challenges determining whether COVID-19 hospitalizations or fatalities are work-related because of COVID-19’s incubation period and the difficulties in tracking the source of exposure. GAO recommends that OSHA determine what additional datamay be neededfrom employers or other sources to better target the agency’s COVID-19 enforcement efforts. The agency neither agreed nor disagreed with this recommendation. Assistance for Fishery Participants The CARES Act appropriated $300 million in March 2020 to the Department of Commerce (Commerce) to assist eligible tribal, subsistence, commercial, and charter fishery participants affected by COVID-19, which may include direct relief payments. After administrative fees were assessed, $298 million of the $300 million appropriated was obligated for fishery participants.Widespread restaurant closures in the spring of 2020 led to a decrease in demand for seafood, adversely affecting the fisheries industry. As of December 4, 2020, all funds had been obligated and only about 18 percent ($53.9 million) of the CARES Act funding obligated for fishery participants had been disbursed, which is inconsistent with Office of Management and Budget guidance on the importance of agencies distributing CARES Act funds in an expedient manner. Commerce’s National Oceanic and Atmospheric Administration (NOAA) officials said they expect that the vast majority of funds will be disbursed to fisheries participants by early 2021. However, the agency does not have the needed information centralized to help ensure that funds are being disbursed expeditiously and efficiently. GAO recommends that NOAA develop a mechanism to track the progress of states, tribes, and territories in meeting established timelines to disburse funds in an expedited and efficient manner. NOAA concurred with this recommendation. Program Integrity GAO continues to identify areas to improve program integrity and reduce the risk of improper payments for programs funded by the COVID-19 relief laws now that federal agencies have obligated a total of $1.9 trillion and expended $1.7 trillion of the $2.7 trillion appropriated for response and recovery efforts as of November 30, 2020. Federal relief programs remain vulnerable to significant risk of fraudulent activities because of the need to quickly provide funds and other assistance to those affected by COVID-19 and its economic effects. In this report, GAO identifies concerns about overpayments and potential fraud in the unemployment insurance (UI) system, specifically in the federally funded Pandemic Unemployment Assistance (PUA) program, which provides UI benefits to individuals not otherwise eligible for these benefits, such as self-employed and certain gig economy workers. As of January 11, 2021, states that had submitted data to DOL reported more than $1.1 billion in PUA overpayments from March through December 2020. While DOL requires states to report data on PUA overpayments, as of the beginning of 2021, the agency was not tracking the amount of overpayments recovered, limiting insight into the effectiveness of states’ efforts to recoup federal funds. To better track the recovery of federal funds, GAO recommends that DOL collect data from states on the amount of PUA overpayments recovered. DOL concurred with this recommendation, and has taken the first step toward implementing it by issuing new guidance and updated instructions for states to report PUA overpayment recovery data. GAO also remains concerned about SBA’s management of internal controls and fraud risks in the Economic Injury Disaster Loans (EIDL) program. COVID-19 relief laws made qualifying small businesses and nonprofit organizations adversely affected by COVID-19 eligible for financial assistance from the EIDL program. Some approval requirements were also relaxed, such as requiring each applicant to demonstrate that it could not obtain credit elsewhere, through December 31, 2021. As of December 31, 2020, SBA officials said they had approved about 3.7 million applications for loans related to COVID-19, totaling about $200 billion. SBA rapidly processed loans and advances to millions of small businesses affected by COVID-19. GAO’s analysis of SBA data shows that the agency approved EIDL loans and advances for potentially ineligible businesses. For example, SBA approved at least 3,000 loans totaling about $156 million to potentially ineligible businesses in industries that SBA policies state were ineligible for the EIDL program, such as insurance and real estate development, as of September 30, 2020. GAO recommends that SBA develop and implement portfolio-level data analytics across EIDL loans and advances made in response to COVID-19 as a means to detect potentially ineligible and fraudulent applications. SBA neither agreed nor disagreed with this recommendation. As of January 15, 2021, the U.S. had about 23 million cumulative reported cases of COVID-19 and more than 387,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of November 30, 2020, of the $2.7 trillion appropriated by these four laws, the federal government had obligated a total of $1.9 trillion and expended $1.7 trillion of the COVID-19 relief funds, as reported by federal agencies. In December 2020, the Consolidated Appropriations Act, 2021, provided additional federal assistance for the ongoing response and recovery. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders. GAO completed its audit work on January 15, 2021. GAO is making 13 new recommendations for agencies that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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