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iauvwK">Resources and Insights</h1><h3 type="h3" color="#ffffff" class="sc-fznyAO dCiajh">Learn more about progress in FDA-authorized trials</h3></div></div><div class="sc-AxirZ sc-AxiKw sc-AxhUy jkjTPd"><div width="100%" class="sc-AxirZ sc-AxiKw gqfTBN"><h2 type="h2" color="#01AE9A" class="sc-fznyAO farSsp">Questions answered by Dr. Peter Marks, Director of the FDA Center overseeing regenerative medicine therapies.</h2><div class="sc-AxirZ sc-AxiKw sc-Axmtr cMTRgb"><a href="https://youtu.be/ryqy89QJ-Iw" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="280px" overflow="hidden" class="sc-AxirZ sc-AxiKw fguPPL"><div style="width:100%;height:100%"></div><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Why Would it be Important to Have a Safe Space to Go?</p></div></div></a><a href="https://youtu.be/8yG71rwYu_g" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="280px" overflow="hidden" 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href="/articles/advancing-the-development-of-safe-and-effective-regenerative-medicine-products.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/advancing-the-development-of-safe-and-effective-regenerative-medicine-products.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Advancing the Development of Safe and Effective Regenerative Medicine Products</p><p class="sc-fznKkj cDvtid">"The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative..."</p></div></div></a><a href="/articles/public-safety-notification-on-exosome-products.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/public-safety-notification-on-exosome-products.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Public Safety Notification on Exosome Products </p><p class="sc-fznKkj cDvtid">“The Food and Drug Administration (FDA) is informing the public, especially patients, health care practitioners, and clinics...”</p></div></div></a><a href="/articles/potential-risks-of-treatment-with-unapproved-regenerative-medicine-products.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/potential-risks-of-treatment-with-unapproved-regenerative-medicine-products.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Potential Risks of Treatment with Unapproved Regenerative Medicine Products</p><p class="sc-fznKkj cDvtid">“Protecting patients is at the core of what we do at the U.S. Food and Drug Administration. Now the FDA is providing additional...”</p></div></div></a><a href="/articles/consumer-alert-on-regenerative-medicine-products-including-stem-cells-and-exosomes-fda.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/potential-risks-of-treatment-with-unapproved-regenerative-medicine-products.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes</p><p class="sc-fznKkj cDvtid">“The US Food and Drug Administration (FDA) has authority to regulate regenerative medicine products, including stem cell...”</p></div></div></a><a href="/articles/identifying-the-risks-of-unproven-regenerative-medicine-therapies.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/identifying-the-risks-of-unproven-regenerative-medicine-therapies.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Identifying the Risks of Unproven Regenerative Medicine Therapies</p><p class="sc-fznKkj cDvtid">“In the middle of the coronavirus disease 2019 (COVID-19) public health response, many priorities are currently competing...”</p></div></div></a><a href="/articles/fda-warns-about-stem-cell-therapies.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/fda-warns-about-stem-cell-therapies.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">FDA Warns About Stem Cell Therapies</p><p class="sc-fznKkj cDvtid">“Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases...”</p></div></div></a><a href="/articles/clarifying-stem-cell-therapy-s-benefits-and-risks.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/clarifying-stem-cell-therapy-s-benefits-and-risks.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Clarifying Stem-Cell Therapy’s Benefits and Risks</p><p class="sc-fznKkj cDvtid">“The current excitement over the potential for stem-cell therapy to improve patient outcomes or even cure diseases...”</p></div></div></a><a href="https://www.youtube.com/watch?v=onnlZeQlai0&feature=emb_title&ab_channel=U.S.FoodandDrugAdministration" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/watch-out-for-unapproved-stem-cell-therapies.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Watch Out for Unapproved Stem Cell Therapies</p><p class="sc-fznKkj cDvtid">“Have you seen ads for stem cell therapies claiming to treat ALS, chronic pain, cancers & more?”</p></div></div></a></div></div><div class="sc-AxirZ sc-AxiKw enZYWx"><h2 type="h2" color="#01AE9A" class="sc-fznyAO farSsp">Manuscripts</h2><div class="sc-AxirZ sc-AxiKw sc-Axmtr cMTRgb"><a href="/articles/unproven-but-profitable-the-boom-in-us-stem-cell-clinics.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/unproven-but-profitable-the-boom-in-us-stem-cell-clinics.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Unproven but Profitable: The Boom in US Stem Cell Clinics</p><p class="sc-fznKkj cDvtid">“Stanford orthopedic surgeon Jason Dragoo, MD, is conducting 4 randomized clinical trials of the use of autologous stem cells...”</p></div></div></a><a href="/articles/a-professional-standard-for-informed-consent-for-stem-cell-therapies.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/a-professional-standard-for-informed-consent-for-stem-cell-therapies.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">A Professional Standard for Informed Consent for Stem Cell Therapies</p><p class="sc-fznKkj cDvtid">“In November 2018, the US Food and Drug Administration (FDA) issued a press release that stated...”</p></div></div></a><a href="/articles/cardiac-stem-cell-therapy-among-clinics-of-uncertain-regulatory-status.pdf" style="letter-spacing:0" target="__blank" class="sc-fzoLsD bgIOlp"><div height="375px" overflow="hidden" class="sc-AxirZ sc-AxiKw hHXJEA"><img height="175px" src="/article-images/cardiac-stem-cell-therapy-among-clinics-of-uncertain-regulatory-status.png" style="object-fit:cover" width="100%" class="sc-AxheI fvRWtq"/><div class="sc-AxirZ kBUaRT"><p font-weight="700" type="large" class="sc-fznKkj eTjHqv">Cardiac Stem Cell Therapy Among Clinics of Uncertain Regulatory Status (COURS)</p><p class="sc-fznKkj cDvtid">“Although a large body of information exists relating to cellular therapies, much of this information is either anecdotal or...”</p></div></div></a></div></div></div><div width="100%" class="sc-AxirZ sc-AxiKw czPtqV"><div style="white-space:pre-wrap" width="100%" class="sc-AxirZ sc-AxiKw eWzpAl"><div width="100%" class="sc-AxirZ sc-AxiKw Eqfgl"><div style="cursor:pointer" class="sc-AxirZ hVmLzB"><div style="transition:color 200ms ease" class="sc-AxirZ sc-AxiKw hgKguh"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="white" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><line x1="12" y1="5" x2="12" y2="19"></line><line x1="5" y1="12" x2="19" y2="12"></line></svg></div></div><div style="white-space:pre-wrap;word-break:break-word" class="sc-AxirZ sc-AxiKw hspBxk"><h3 type="h3" color="#01AE9A" font-weight="700" style="cursor:pointer" class="sc-fznyAO ijhUgy">The True Trials Map</h3><div overflow="hidden" style="transition:max-height 200ms ease" class="sc-AxirZ sc-AxiKw YYzbd"><p class="sc-fznKkj cDvtid">In an effort to improve awareness and increase patient access to credible trials in regenerative medicine across a range of indications, True Trials has created a user-friendly, interactive map with a list of target diseases. This map identifies the locations of only those clinics with FDA-authorized regulatory status. Using this resource, patients will readily find and consider participation in regulated clinical trials. Such a tool will - for the first time - help patients specifically concentrate their interest and exploration on regenerative medicine clinical programs that have the data requisite to qualify for and conduct a clinical trial with FDA authorization.</p><div display="block" overflow="none" width="100%,100%,640px" class="sc-AxirZ hoFUQ"><div style="width:100%;height:360px"></div></div></div></div></div><div width="100%" class="sc-AxirZ sc-AxiKw Eqfgl"><div style="cursor:pointer" class="sc-AxirZ hVmLzB"><div style="transition:color 200ms ease" class="sc-AxirZ sc-AxiKw hgKguh"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="white" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><line x1="12" y1="5" x2="12" y2="19"></line><line x1="5" y1="12" x2="19" y2="12"></line></svg></div></div><div style="white-space:pre-wrap;word-break:break-word" class="sc-AxirZ sc-AxiKw hspBxk"><h3 type="h3" color="#01AE9A" font-weight="700" style="cursor:pointer" class="sc-fznyAO ijhUgy">What about ClinicalTrials.gov?</h3><div overflow="hidden" style="transition:max-height 200ms ease" class="sc-AxirZ sc-AxiKw YYzbd"><p class="sc-fznKkj cDvtid">The listings on clinicaltrials.gov are not screened with respect to FDA authorization, so having a listing on clinicaltrials.gov does not in any way mean that it is an FDA-authorized trial. For example, of the 207 results for a search of “mesenchymal stem cell” on clinicaltrials.gov, 86 list that they are studying an FDA-regulated drug or device, however, these do not actually indicate that they possess FDA-authorization via IND or IDE. Prospective patients are often unaware of this distinction.</p><div display="none" overflow="none" width="100%,100%,640px" class="sc-AxirZ bixlXF"><div style="width:100%;height:360px"></div></div></div></div></div><div width="100%" class="sc-AxirZ sc-AxiKw Eqfgl"><div style="cursor:pointer" class="sc-AxirZ hVmLzB"><div style="transition:color 200ms ease" class="sc-AxirZ sc-AxiKw hgKguh"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="white" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><line x1="12" y1="5" x2="12" y2="19"></line><line x1="5" y1="12" x2="19" y2="12"></line></svg></div></div><div style="white-space:pre-wrap;word-break:break-word" class="sc-AxirZ sc-AxiKw hspBxk"><h3 type="h3" color="#01AE9A" font-weight="700" style="cursor:pointer" class="sc-fznyAO ijhUgy">What is the FDA doing to help?</h3><div overflow="hidden" style="transition:max-height 200ms ease" class="sc-AxirZ sc-AxiKw YYzbd"><p class="sc-fznKkj cDvtid">The US Food and Drug Administration (FDA) has the authority to regulate regenerative medicine products, including stem cell products and exosome products. There is a lot of misleading information on the internet about these products, including statements about the conditions they can be used to treat. The FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. The FDA wants to help consumers be informed about how these products are regulated when considering treatment. Stem cell products are regulated by the FDA, and all stem cell products require FDA authorization. Patients should be cautious of any clinics, including regenerative medicine clinics or healthcare providers, including physicians, chiropractors, or nurses, that advertise or offer such products commercially outside of an authorized clinical trial setting at a trusted institution or hospital.</p><div display="block" overflow="none" width="100%,100%,640px" class="sc-AxirZ hoFUQ"><div style="width:100%;height:360px"></div></div></div></div></div><div width="100%" class="sc-AxirZ sc-AxiKw Eqfgl"><div style="cursor:pointer" class="sc-AxirZ hVmLzB"><div style="transition:color 200ms ease" class="sc-AxirZ sc-AxiKw hgKguh"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="white" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><line x1="12" y1="5" x2="12" y2="19"></line><line x1="5" y1="12" x2="19" y2="12"></line></svg></div></div><div style="white-space:pre-wrap;word-break:break-word" class="sc-AxirZ sc-AxiKw hspBxk"><h3 type="h3" color="#01AE9A" font-weight="700" style="cursor:pointer" class="sc-fznyAO ijhUgy">Why TrueTrials?</h3><div overflow="hidden" style="transition:max-height 200ms ease" class="sc-AxirZ sc-AxiKw YYzbd"><p class="sc-fznKkj cDvtid">Several high-visibility publications have provided maps and expositions of clinics with uncertain ethical and safety standards, advising people where not to go for treatment. The TrueTrials team believes that patients in need are particularly well-served by a more positive approach that shows them where they can and should go for treatment. TrueTrials uniquely features FDA-authorized clinical studies in regenerative medicine, including FDA-authorization numbers, targeted diseases, test agent identities, locations and contact information. This information is provided to the public using the optimized, accessible TrueTrials map. The map links a geographic site locator with the disease targets based on medical need, site location, and other key features.</p><div display="block" overflow="none" width="100%,100%,640px" class="sc-AxirZ hoFUQ"><div style="width:100%;height:360px"></div></div></div></div></div><div width="100%" class="sc-AxirZ sc-AxiKw Eqfgl"><div style="cursor:pointer" class="sc-AxirZ hVmLzB"><div style="transition:color 200ms ease" class="sc-AxirZ sc-AxiKw hgKguh"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="white" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><line x1="12" y1="5" x2="12" y2="19"></line><line x1="5" y1="12" x2="19" y2="12"></line></svg></div></div><div style="white-space:pre-wrap;word-break:break-word" class="sc-AxirZ sc-AxiKw hspBxk"><h3 type="h3" color="#01AE9A" font-weight="700" style="cursor:pointer" class="sc-fznyAO ijhUgy">Helping the field of Regenerative Medicine</h3><div overflow="hidden" style="transition:max-height 200ms ease" class="sc-AxirZ sc-AxiKw YYzbd"><p class="sc-fznKkj cDvtid">We believe that this approach will serve the mutual interests of a wide range of stakeholders in the field. Patient education about trial existence will facilitate accelerated trial enrollment and maximize efficiency of resource utilization. The availability of this information will provide a safeguard for patients when selecting providers, limiting exposure to clinics that are not using an FDA-authorized approach and instead increasing access to clinics with known FDA-compliant regulatory status.</p><div display="block" overflow="none" width="100%,100%,640px" class="sc-AxirZ hoFUQ"><div style="width:100%;height:360px"></div></div></div></div></div></div></div></div></div><div class="sc-AxirZ sc-AxiKw NECl"><div width="100%" class="sc-AxirZ sc-AxiKw eWzpAl"><div width="100%" class="sc-AxirZ sc-AxiKw dMaKIm"><img height="6rem" src="misc/TTLogoHorizontalFullColor.svg" class="sc-AxheI fQVMni"/></div><hr width="100%" class="sc-fzplWN eXjDbK"/><div width="100%" class="sc-AxirZ sc-AxiKw sc-Axmtr jRLKnV"><div spacing="6" class="sc-AxirZ sc-AxgMl gqZYqm"><p color="#003753" font-weight="700" class="sc-fznKkj gjKJRi">Company</p><a href="/" class="sc-fzqBZW eNQuho">Home</a><a href="/find-trials" class="sc-fzqBZW eNQuho">Find Trials</a><a href="/about-us" class="sc-fzqBZW eNQuho">About Us</a><a href="/resources" class="sc-fzqBZW eNQuho">Resources</a><a href="/investigators" class="sc-fzqBZW eNQuho">Investigators</a><a href="/contact-us" class="sc-fzqBZW eNQuho">Contact Us</a></div><div spacing="6" class="sc-AxirZ sc-AxgMl gqZYqm"><p color="#003753" font-weight="700" class="sc-fznKkj gjKJRi">Legal</p><a href="/cookie-policy" class="sc-fzqBZW eNQuho">Cookie Policy</a><a href="/privacy-policy" class="sc-fzqBZW eNQuho">Privacy Policy</a><a href="/terms-and-conditions" class="sc-fzqBZW eNQuho">Terms & Conditions</a></div><div style="grid-column:span 3" class="sc-AxirZ sc-AxiKw cuYnvQ"><div spacing="6" class="sc-AxirZ sc-AxgMl hbSRUn"><p color="#003753" font-weight="700" class="sc-fznKkj gjKJRi">Partners</p><div class="sc-AxirZ sc-AxiKw fNMHQp"><img alt="sanford" height="48px" src="partners/sanfordHealth.png" width="auto" class="sc-AxheI bjkIFr"/><img alt="EWF" height="48px" src="partners/emilyWhiteheadFoundationFooter.png" width="auto" class="sc-AxheI duIWQF"/><img alt="cookMyosite" height="48px" src="partners/cookMyosite.png" width="auto" class="sc-AxheI duIWQF"/><img alt="mayoClinic" height="48px" src="partners/mayoClinic.png" width="auto" class="sc-AxheI jXduUo"/></div></div><div spacing="6" class="sc-AxirZ sc-AxgMl efEZfU"><p color="#003753" font-weight="700" class="sc-fznKkj gjKJRi">Supportive Organizations</p><img alt="ifats" height="48px" src="supportive-organizations/ifats-logo.svg" width="auto" class="sc-AxheI hHgPNI"/></div></div></div><hr width="100%" class="sc-fzplWN kCBpm"/><div class="sc-AxirZ sc-AxiKw ivZHOE"><div class="sc-AxirZ sc-AxiKw dBRIV"><p color="#333333" opacity="0.6" class="sc-fznKkj iTfIjc">© 2023 True Trials, Inc. 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fill="#333333"></path></svg></div>chameleon</a></div></div></div></div><div style="display:none" class="sc-AxirZ sc-AxiKw sc-fzqNJr dwuxqG"><div overflow="auto" class="sc-AxirZ sc-AxiKw sc-fzoyAV bhjaxe"><div width="100%" class="sc-AxirZ sc-AxiKw sc-AxhUy XnaQi"><h3 type="h3" class="sc-fznyAO dUKywV">Request Inclusion on TrueTrials Map</h3><div display="flex" width="90%" class="sc-AxirZ fuAbCZ"><p class="sc-fznKkj ecHyyb">TrueTrials requires that your answer to the following questions be "yes" to be eligible for TrueTrials inclusion.</p><ol style="color:#003753;list-style-position:inside;list-style-type:decimal;margin:0.5rem 1rem"><li>Does your trial use a cellular product?<ul style="color:#003753;list-style-position:inside;list-style-type:circle;margin:0.5rem 1rem"><li>Somatic cells</li><li>Multicellular fractions containing stem cells (eg, SVF or BMA)</li><li>Stem cells</li><li>Scaffold-based cellular products</li><li>Adoptive cell therapy (eg, CAR-T, TCR-T, TIL)</li><li>Acellular components (eg, exosomes, secretomes, PRP)</li><li>Other</li></ul></li><li style="margin-bottom:0.5rem">Has your team received confirmation to proceed with clinical trials after IND or IDE application?</li><li style="margin-bottom:0.5rem">Has your team received an Institutional Review Board approval letter?</li><li>Is the trial currently enrolling patients?</li></ol><p class="sc-fznKkj ecHyyb">If you can answer yes to all of the above criteria, please click "Yes" below, otherwise, click "No" for more information and support.</p><div class="sc-AxirZ sc-AxiKw iDlcrZ"><a class="sc-fznZeY eqAeKx">Yes</a><a class="sc-fznZeY kquwMF">No</a></div></div><div display="none" width="90%" class="sc-AxirZ jwsvQ"><p class="sc-fznKkj ecHyyb">Your response suggests your trial does not fit the criteria for the types of trials TrueTrials is enrolling. These criteria are:</p><ol style="color:#003753;list-style-position:inside;list-style-type:decimal;margin:0.5rem 1rem"><li>Cell-based therapy</li><li>IND/IDE authorized</li><li>IRB approved</li><li>Currently enrolling</li></ol><div class="sc-AxirZ sc-AxiKw iDlcrZ"><p class="sc-fznKkj ecHyyb">If you would like to see TrueTrial's eligibility decision tree click </p><a href="/misc/decisiontree.png" style="color:#003753;letter-spacing:normal;text-decoration:underline" target="blank">here.</a></div><p style="margin-top:0.5rem" class="sc-fznKkj ecHyyb">Do you think your trial still qualifies? If so, please send of an email requesting consultation at info@truetrials.org. Thank you for reaching out to TrueTrials and working to meet patient needs!</p><a style="text-decoration:underline" class="sc-fznZeY fSmBSQ">Back</a></div><form display="none" width="90%" class="sc-AxirZ jwsvQ"><input type="text" font-size="16" name="name" placeholder="Trial Coordinator Name*" class="sc-AxmLO hoqlCr"/><input type="email" font-size="16" name="email" placeholder="Coordinator Email*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="study" placeholder="Study Name*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="investigator" placeholder="Investigator or Industrial Sponsor Name*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="site" placeholder="Site Name*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="indNumber" placeholder="IND Number*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="nctNumber" placeholder="NCT Number*" class="sc-AxmLO hoqlCr"/><p class="sc-fznKkj kaiycf">Current Status</p><div width="100%" class="sc-AxirZ sc-AxiKw gcZDWs"><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">Not Yet Recruiting</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">Recruiting</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">Expanded Access</p></div></div><input type="text" font-size="16" name="targetCondition" placeholder="Target Condition*" class="sc-AxmLO hoqlCr"/><input type="text" font-size="16" name="investigativeAgent" placeholder="Investigative Agent*" class="sc-AxmLO hoqlCr"/><p class="sc-fznKkj kaiycf">Phase</p><div width="100%" class="sc-AxirZ sc-AxiKw gcZDWs"><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">1</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">2a</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">2b</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">3</p></div><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">4</p></div></div><p class="sc-fznKkj kaiycf">Provide a patient-friendly brief summary of the key requisite inclusion criteria for participation in this trial:</p><textarea font-size="16" maxLength="250" name="keyInclusionCriteria" placeholder="Key Inclusion Criteria*" class="sc-fzozJi bqIZUe"></textarea><p class="sc-fznKkj kaiycf">Provide a patient-friendly brief summary of the key requisite exclusion criteria for participation in this trial:</p><textarea font-size="16" maxLength="250" name="keyExclusionCriteria" placeholder="Key Exclusion Criteria*" class="sc-fzozJi bqIZUe"></textarea><input type="text" font-size="16" name="irbName" placeholder="IRB Name*" class="sc-AxmLO hoqlCr"/><input type="file" formEncType="multipart/form-data" style="display:none" class="sc-AxmLO AQDBk"/><input display="none" name="_honeypot" class="sc-AxmLO yplOx"/><p class="sc-fznKkj iVuusm">Please attach FDA authorization communication that you received by email or on letterhead. Alternatively, you may forward the email you received to info@truetrials.org</p><a class="sc-fznZeY fyisBA">Attach File</a><div style="cursor:pointer" class="sc-AxirZ sc-AxiKw hpPjwD"><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none" stroke="#00375366" stroke-width="2" stroke-linecap="round" stroke-linejoin="round"><rect x="3" y="3" width="18" height="18" rx="2" ry="2"></rect></svg><p font-weight="700" opacity="0.4" style="margin-left:8px;max-width:90%" class="sc-fznKkj kkMBwZ">I confirm that the above information is current, and I consent to TrueTrials requesting status updates, sent to the Trial Coordinator information provided, approximately every two months to help ensure high-quality, up-to-date patient service.</p></div><p color="#B71C1C" font-size="14" opacity="0" class="sc-fznKkj ekkjmg">Checkbox is required.</p><a class="sc-fznZeY eqAeKx">Submit</a><a style="text-decoration:underline" class="sc-fznZeY fSmBSQ">Back</a></form></div></div></div></div><style data-emotion-css="1f0mbsd">.css-1f0mbsd{box-sizing:border-box;max-height:100%;overflow-x:hidden;overflow-y:auto;padding:8px;pointer-events:none;position:fixed;z-index:1000;bottom:0;left:50%;-webkit-transform:translateX(-50%);-ms-transform:translateX(-50%);transform:translateX(-50%);}</style><div class="react-toast-notifications__container css-1f0mbsd"></div></div><script id="__NEXT_DATA__" type="application/json">{"props":{"pageProps":{}},"page":"/resources","query":{},"buildId":"m1A3STBKPGgnyhZA-vxeL","nextExport":true,"autoExport":true,"isFallback":false,"scriptLoader":[]}</script></body></html>