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Patients seeking stem cell therapies-a prospective qualitative analysis from a Regenerative Medicine Consult Service.

ABSTRACT: Despite patient demand for stem cell therapies (SCTs) for musculoskeletal conditions, there remains limited research on why patients seek SCTs or their sources of information. We employ three questions into a consult intake form: (1) Why are you interested in stem cell treatment for your condition? (2) How did you find out about stem cell treatment for your condition? (3) Have you contacted a stem cell clinic? Responses analyzed, using a qualitative content analysis approach to identify themes reveal many patients seek SCTs to treat pain or delay surgery which may align with some current clinical evidence while other patients express motivations as expected outcomes (e.g., SCTs are better than standard of care or can regenerate tissue) which are not supported by current medical evidence. These differences suggests that patient-centered counseling may help patients by addressing misconceptions and increasing health literacy about expected outcomes of SCTs for treating musculoskeletal conditions.

SUBMITTER: Arthurs JR

PROVIDER: S-EPMC8956610 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Patients seeking stem cell therapies-a prospective qualitative analysis from a Regenerative Medicine Consult Service.

Arthurs Jennifer R JR Nordan Lisa M LM Hultgren Brian H BH Heckman Michael G MG Martinez Dayana D Master Zubin Z Shapiro Shane A SA

NPJ Regenerative medicine 20220325 1

Despite patient demand for stem cell therapies (SCTs) for musculoskeletal conditions, there remains limited research on why patients seek SCTs or their sources of information. We employ three questions into a consult intake form: (1) Why are you interested in stem cell treatment for your condition? (2) How did you find out about stem cell treatment for your condition? (3) Have you contacted a stem cell clinic? Responses analyzed, using a qualitative content analysis approach to identify themes r ...[more]

PMID: 35338147

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Project description:BACKGROUND:As the drug poisoning crisis worsens in North America and opioid use disorder (OUD)-related hospital admissions increase, policymakers and hospital administrators are beginning to recognize the important role of hospitals in the OUD care continuum. This study explores and describes how U.S. addiction medicine physicians created and presented business propositions to hospital administrators to support the development of addiction medicine consult (AMC) services. METHODS:Fifteen qualitative interviews were completed with board-certified or board-eligible addiction medicine physicians from 14 U.S. hospitals. The interviews occurred as part of a broader mixed methods study exploring hospital service delivery for patients admitted with OUD. Using a directed content analysis, the transcribed interviews were coded, analyzed, and final themes consolidated. RESULTS:Semi-structured interviews completed with addiction medicine physicians from established (n = 9) and developing (n = 5) AMC services at 14 U.S. hospitals explored how clinical champions persuaded hospital administrators to support AMC service development. Four elements were foundational to making the "business case": 1) describing the prevalence of substance use disorder (SUD) or OUD in the hospital; 2) identifying the negative financial impacts of not treating SUDs during hospitalization; 3) highlighting the ongoing care quality and treatment gap for hospitalized patients with SUDs; and 4) noting the success of other institutional AMC services. Study findings informed the creation of tools to support AMC service development: 1) an AMC service business case template, and 2) an AMC service design and operations resource list. CONCLUSIONS:OUD-related hospital admissions are unlikely to abate. Hospital administrators should consider innovative care delivery mechanisms to improve care for persons with OUD. AMC services may be a promising delivery mechanism to achieve this aim. For clinical and administrative champions, understanding how to communicate the potential effectiveness of this intervention to hospital leaders is an essential first step to AMC service creation.

Project description:The field of regenerative medicine is growing rapidly with the introduction of new therapies that have the potential to treat and cure serious medical conditions, including rare diseases, for which there are no available treatments. In the United States, the development of novel medical products is regulated and guided by the Food and Drug Administration (FDA). As scientific and technological advances are discovered and adopted by the medical industrial enterprise, the FDA's implementation of policies that create a climate conducive to safe development and rapid availability of novel medical products is one of the pillars which support the Agency's mission of protecting and promoting the public health. With advancements in cell modifications and tissue engineering, innovative creation of biomaterials, adoption of three-dimensional bioprinting, and rapid development of human genome editing technologies, the need for Agency's work in ensuring that its science-based policies remain relevant and helpful in facilitating the availability of new treatments to the most vulnerable populations of patients becomes more pressing than ever before. In December 2016, Congress amended section 506 of the Food, Drug, and Cosmetic (FD&C) Act [21 U.S.C. 356] by adding a new section 506(g), which defines the categories of products considered to be regenerative medicine therapies. As further described by FDA [1], regenerative medicine therapies are considered to include cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies, as well as gene therapies, including genetically modified cells that lead to a durable modification of cells or tissues. The development and approval of regenerative medicine therapies are regulated by FDA's Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER). In this review article, we present practical considerations for investigating regenerative medicine therapies intended for the treatment of rare diseases. The material presented may be useful to researchers who are undertaking the challenging task of finding and delivering new treatments for those in need.

Dataset Information

Patients seeking stem cell therapies-a prospective qualitative analysis from a Regenerative Medicine Consult Service.

Publications

Patients seeking stem cell therapies-a prospective qualitative analysis from a Regenerative Medicine Consult Service.

Similar Datasets

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