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  • Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (ALCHEMIST) Rochester, Minn.

    This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

  • Center for Regenerative Medicine Biotrust Biomaterial Repository Rochester, Minn.

    The purpose of this study is the growing and storage of stem cells, made using the tissue samples of patients and others. As new technologies develop, these cells may be able to be grown into new cells to replace those damaged by disease or injury.

  • DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101) Rochester, Minn.

    The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features. 

  • Long Term Evaluation of Thymoma Recurrence Rochester, Minn.

    The purpose of this study is to evaluate thymoma recurrence rates in patients who underwent thymectomy.

  • NAUTIKA1: Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (NAUTIKA1) Rochester, Minn.

    The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.

  • Neonatally-derived Tissues for Regenerative Biotherapeutic Development Rochester, Minn.

    This purpose of this study is to centralize the collections of human blood products and tissue samples for the purpose of establishing a resource for those investigating regenerative medicine as a therapy. Its overall goal is to produce a Good Manufacturing Practice compliant, allogeneic therapeutic cell bank whereby therapeutic progenitor cells are obtained from perinatal tissue and/or their acellular derivatives and umbilical cord blood collected from consented donors who meet 21 CFR 1271 donor eligibility criteria. Ultimately, to develop procedures detailing the isolation and expansion of progenitor cells and products derived from these cells such as extracellular vesicles for development of pre-clinical analysis to gather the data for future Investigational New Drug (IND) submissions to the FDA.

  • Progenitor Cells for Patients with Degenerative Lung Disease Rochester, Minn.

    The purpose of this study is to use a patient's own cells to fabricate a recellularized scaffold to repopulate the lung and restore function that could offer a solution for patients with degenerative lung disease.

  • Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement Rochester, Minn. Cellspan™ Esophageal Implant-Adult (CEI) The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living biologic esophageal conduit, in patients requiring full circumferential esophageal reconstruction up to 6 cm segment in length. This is a single arm, unblinded, multicenter, prospective first-in-human (FIH) feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will be followed for a minimum of 2 years post-implant surgery. Since this is an FIH experience, the study will utilize an independent Data Monitoring Committee (DMC) to evaluate safety on a continuous basis to mitigate any safety risks to subjects. A sentinel approach to enrollment of subjects shall be guided by the DMC review of cases.
  • Stem Cell Based Therapeutics for Chronic Disease Rochester, Minn.

    The purpose of this study is to produce, using current Good Manufacturing Practices (cGMPs), a bank of 50 primary fibroblast cell lines from skin biopsies obtained by consenting donors who meet 21 CFR 1271 donor eligibility criteria, and to use fibroblasts in the cell bank generated in aim 1 to produce new induced pluripotent stem cell lines using Good Manufacturing Practices (cGMPs). These iPSC lines will then be screened to identify those with optimal characteristics for treatment purposes, as well as for the potential generation of transplantable tissues and therapeutics for chronic disease.

  • Surgery for Mesothelioma After Radiation Therapy “SMART” for Resectable Malignant Pleural Mesothelioma (SMART) Rochester, Minn.

    The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.  

Closed for Enrollment

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