Biostage Activated Mayo Clinic as The First Site for Clinical Trial in Severe Esophageal Disease
Biostage, Inc. (OTCQB: BSTG) has officially activated Mayo Clinic as the first site for its clinical trial in severe esophageal disease. This marks Biostage's first clinical trial in the United States for its esophageal implant technology, which aims to regenerate organs inside the body. The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus due to cancer, trauma, or birth defects.
The study will be conducted at up to five hospitals in the U.S., with the primary endpoint being the development of a continuous biological neo-conduit at three months following implantation. This milestone represents a significant step forward for Biostage in its mission to advance organ regeneration and regenerative medicine.
Biostage, Inc. (OTCQB: BSTG) ha ufficialmente attivato la Mayo Clinic come primo sito per il suo studio clinico sulla malattia esofagea grave. Questo segna il primo studio clinico di Biostage negli Stati Uniti per la sua tecnologia di impianto esofageo, che mira a rigenerare organi all'interno del corpo. Lo studio di Fase 1, primo nell'uomo approvato dalla FDA valuterà sia la sicurezza che l'efficacia su un massimo di dieci pazienti che necessitano della rimozione di fino a 6 cm del loro esofago a causa di cancro, traumi o difetti congeniti.
Lo studio verrà condotto in un massimo di cinque ospedali negli Stati Uniti, con l'obiettivo primario che è lo sviluppo di un neocondotto biologico continuo a tre mesi dall'impianto. Questo traguardo rappresenta un passo significativo per Biostage nella sua missione di avanzare nella rigenerazione degli organi e nella medicina rigenerativa.
Biostage, Inc. (OTCQB: BSTG) ha activado oficialmente a la Clínica Mayo como el primer sitio para su ensayo clínico en enfermedad esofágica severa. Esto marca el primer ensayo clínico de Biostage en los Estados Unidos para su tecnología de implante esofágico, que tiene como objetivo regenerar órganos dentro del cuerpo. El estudio de Fase 1, primer en humanos aprobado por la FDA evaluará tanto la seguridad como la eficacia en hasta diez pacientes que requieren la extirpación de hasta 6 cm de su esófago debido a cáncer, trauma o defectos congénitos.
El estudio se llevará a cabo en hasta cinco hospitales en EE.UU., con el objetivo principal de desarrollar un neoconducto biológico continuo a los tres meses posteriores a la implantación. Este hito representa un paso importante para Biostage en su misión de avanzar en la regeneración de órganos y la medicina regenerativa.
Biostage, Inc. (OTCQB: BSTG)는 메이요 클리닉을 중증 식도 질환에 대한 임상 시험의 첫 번째 장소로 공식적으로 활성화했습니다. 이는 Biostage의 식도 임플란트 기술에 대한 미국 내 첫 번째 임상 시험으로, 이는 신체 내 장기를 재생하는 것을 목표로 합니다. FDA에 의해 승인된 1상, 최초의 사람 대상 연구는 암, 외상 또는 선천적 결함으로 인해 최대 6cm의 식도를 제거해야 하는 최대 10명의 환자에서 안전성과 유효성을 평가할 것입니다.
이 연구는 미국 내 최대 5개 병원에서 실시될 예정이며, 주요 목표는 이식 후 3개월 동안 지속적인 생물학적 신관의 개발입니다. 이 이정표는 Biostage가 장기 재생 및 재생 의학을 발전시키겠다는 사명을 수행하는 데 중요한 진전을 나타냅니다.
Biostage, Inc. (OTCQB: BSTG) a officiellement activé la Mayo Clinic comme premier site pour son essai clinique sur la maladie œsophagienne sévère. Cela marque le premier essai clinique de Biostage aux États-Unis pour sa technologie d'implant œsophagien, qui vise à régénérer les organes à l'intérieur du corps. L'étude de Phase 1, premier essai chez l'homme approuvée par la FDA évaluera à la fois la sécurité et l'efficacité chez jusqu'à dix patients nécessitant l'ablation de jusqu'à 6 cm de leur œsophage en raison de cancer, de traumatismes ou de malformations congénitales.
L'étude sera réalisée dans jusqu'à cinq hôpitaux aux États-Unis, l'objectif principal étant le développement d'un néoconduit biologique continu trois mois après l'implantation. Ce jalon représente un pas important pour Biostage dans sa mission de faire avancer la régénération des organes et la médecine régénérative.
Biostage, Inc. (OTCQB: BSTG) hat offiziell die Mayo Klinik als ersten Standort für seine klinische Studie zur schweren Speiseröhrenkrankheit aktiviert. Dies markiert die erste klinische Studie von Biostage in den Vereinigten Staaten für seine Speiseröhrenimplantat-Technologie, die darauf abzielt, Organe im Körper zu regenerieren. Die von der FDA genehmigte Phase 1, erste Studie am Menschen wird sowohl die Sicherheit als auch die Wirksamkeit bei bis zu zehn Patienten bewerten, die aufgrund von Krebs, Trauma oder Geburtsfehlern bis zu 6 cm ihrer Speiseröhre entfernt werden müssen.
Die Studie wird in bis zu fünf Krankenhäusern in den USA durchgeführt, wobei das Hauptziel die Entwicklung eines kontinuierlichen biologischen Neokondits drei Monate nach der Implantation ist. Dieser Meilenstein stellt einen bedeutenden Fortschritt für Biostage in seiner Mission dar, die Organregeneration und regenerative Medizin voranzutreiben.
- Activation of Mayo Clinic as the first site for clinical trial
- FDA approval for Phase 1 first-in-human study
- Potential to treat severe esophageal diseases including cancer, trauma, and birth defects
- Study to be conducted in up to five hospitals in the U.S.
- None.
"We are thrilled to announce the initiation of our first clinical study for our esophageal implant, marking an important milestone for Biostage," said Jerry He, Chairman and CEO of Biostage. "Our numerous preclinical studies have demonstrated our technology as an effective platform for tubular organ regeneration. We look forward to testing the esophageal implant in the clinics as we further our understanding of its potential benefits for patients. As a leader in the field of organ regeneration and regenerative medicine, we feel a strong sense of responsibility to act swiftly to bring better treatment for suffering patients as soon as possible," Jerry further emphasized.
Dr. Shunfu Hu, VP of Operations and Business Development, commented with his excitement, "After years of collaboration with the Mayo Clinic, we are thrilled that our innovative organ regeneration platform is undergoing clinical trial evaluation, ready to recruit patients in the US."
The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus (including cancer, trauma or birth defects) at up to five hospitals in the
Further details of the study are posted on clinicaltrials.gov.
About Biostage
We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient's own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient's own organs or permanent artificial implants.
We conducted the world's first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Denis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.
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Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company's products, by the
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Chief Financial Officer
774-233-7330
jdamasio@biostage.com
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SOURCE Biostage, Inc.
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