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Clinical Studies

Closed for Enrollment

  • A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients with High, Transsphincteric Cryptoglandular Perianal Fistulas Rochester, Minn.

    The purpose of this study is to assess the safety of autologous mesenchymal stromal (stem) cell transfer using a biomatrix (the Gore Fistula Plug) to treat perianal fistula.

  • A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's Disease Rochester, Minn.

    The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

  • Colon and Rectal Surgery Patient Fitness and Prehabilitation Program Survey during COVID 19 Pandemic (POWER survey) Rochester, Minn.

    The primary aim of this study is to assess colon and rectal surgery patient perceptions of physical fitness, willingness to participate in a prehabilitation program, access to cardiovascular and strength training equipment, and impact of the COVID19 pandemic on fitness and health. The secondary aim is to evaluate if patient’s perceptions of physical fitness correlate with baseline demographic and health variables and outcomes following surgery.

  • Quality of Life after Surgery for Recurrent Rectal Cancer (10Ten Study) Rochester, Minn.

    The purpose of this study is to measure the quality and quantity of the lifespan in patients who have locally recurrent rectal cancer. It will compare survival rates and quality of life of those who have surgery to those who do not have surgery. It also aims to compare certain other factors, such as whether clear resection margins (i.e. “R0 margins” which are when no evidence of the tumour is found in the biopsy) were achieved and the influence of chemotherapy and radiotherapy.

  • Quality of Life in Rectal Cancer Patients with Lynch Syndrome Rochester, Minn.

    The purpose of this study is to show the quality of life and bowel function in patients who have been diagnosed with rectal cancer and are known to have Hereditary Nonpolyposis Colorectal Cancer (HNPCC), especially to make comparisons between clinical managements, family history, and health behaviors.