Researchers at Mayo Clinic are studying regenerative medicine techniques for restoring tissue and organ function.

Active clinical trials include:

Clinical Trials

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13 studies in Center for Regenerative Medicine

  1. A PROSPECTIVE STUDY OF PATIENTS WITH HYPOPLASTIC LEFT HEART SYNDROME FOLLOWING STAGE II SURGICAL PALLIATION
    Rochester, Minn. View Summary

    A PROSPECTIVE STUDY OF PATIENTS WITH HYPOPLASTIC LEFT HEART SYNDROME FOLLOWING STAGE II SURGICAL PALLIATION

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol starting within days of birth. Stage I of this process is the Norwood reconstruction (within the first few days of life), Stage II (usually required within 3-8 months) involves creation of a direct connection between the patient's superior vena cava and the pulmonary arterial confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan circulation (typically within the first 2-4 years). This "single ventricle" approach requires the right ventricle to perform as the only circulatory pump for the entire body. Our long-term goal is to develop regenerative strategies to strengthen and augment the right ventricular muscle of the single-ventricle heart following surgical palliation in HLHS patients. To determine the safety and feasibility of a cell-based therapeutic intervention at the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS patients having undergone standard of care with protocol specific follow-up over the course of a 6-month period. This prospective study will document the natural history in patients with HLHS after planned Stage II surgical palliation with a focus on cardiovascular parameters within 6 months following surgery in 10-20 patients.

    NCT ID:

    NCT01708863

    IRB Number:

    12-002887

    Who can I contact for additional information about this study?

    Rochester: Karen P Krucker, RN 507-255-4774
                        


  2. A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis
    Rochester, Minn. View Summary

    A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objective of this study is to determine the safety of intrathecal delivery of autologous mesenchymal stem cells (MSCs) to the cerebrospinal fluid (CSF) of patients with ALS using a dose-escalation study. The trial will include 25 adult, non-ventilator-dependent patients with clinically definite amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue, expanded ex vivo and then, after ~8 weeks, intrathecal (IT) autologous delivery of MSCs will be performed. There will be 5 treatment groups of up to 5 patients each. Groups 1, 2, and 4 will receive a single dose of cells. Groups 3 and 5 will receive 2 doses of cells separated by 1 month. Groups will be completed sequentially so that patients will not be enrolled into the next treatment group until at least 3 patients in the preceding group have completed the treatment and 1 month of additional observation without significant toxicity. All patients will be followed on a regular basis until death or for a minimum of 2 years after completion of the final infusion. Initial clinical follow-up will be weekly with scheduled blood, CSF and magnetic resonance imaging (MRI) evaluations. After 1 month, patients will have clinical evaluations at 3 month intervals, or earlier if indicated by clinical status.

    NCT ID:

    NCT01609283

    IRB Number:

    11-008415

    Who can I contact for additional information about this study?

    Rochester: Delana Weis 507-266-7196
                        Nathan P. Staff, MD, PhD 507-284-2511


  3. Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome
    Rochester, Minn. View Summary

    Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is a Phase I trial to determine the safety of autologous mononuclear cells (MNC) derived from umbilical cord blood for intramyocardial delivery into the right ventricle during a planned and non-emergent Stage II surgical palliation in subjects with HLHS. This is the first critical step towards applying autologous MNC therapy as an add-on regenerative intervention for congenital heart disease management. The choice of HLHS as the target disease for regenerative therapies in congenital heart disease management is multi-factorial and includes the following considerations: 1) Severity of of this incurable disease, 2) palliative nature and burden of long-term outcomes with a single right ventricular system, 3) three stages of planned surgical procedures that provide time points to adjunctively intervene, and 4) prenatal diagnosis enabling planned collection of UCB. An emerging goal for cardiac regeneration includes the application of cell-based technology to congenital heart disease, which is a favorable substrate due to the lack of fibrotic scaring, and the presence of a microenvironment that is expected to support ongoing cardiac proliferation and growth for functional remuscularization. This Phase I safety study will determine the feasibility of collection, processing, and delivery of autologous cells as used in adult cardiac regenerative protocols in the setting of HLHS surgical management.

    NCT ID:

    NCT01883076

    IRB Number:

    12-008521

    Who can I contact for additional information about this study?

    Rochester: Julia Thebiay 507-538-8425
                        


  4. A Phase I Study of iPS Cell Generation From Patients With COPD
    Rochester, Minn. View Summary

    A Phase I Study of iPS Cell Generation From Patients With COPD

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

    NCT ID:

    NCT01860898

    IRB Number:

    09-005334

    Who can I contact for additional information about this study?

  5. Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
    Rochester, Minn. View Summary

    Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally growing and may be the most amendable to regenerative strategies. Therefore, identifying autologous cells (cells from the patient's own body) would be important to initiate these studies. This study aims to validate the use of umbilical cord blood as a source of autologous cells for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from the cord blood to help us determine the feasibility of collection, processing, and storage of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left heart syndrome. This study may be useful for the development of pre-clinical and clinical studies aimed at the long-term goal of repairing damaged heart muscle.

    NCT ID:

    NCT01856049

    IRB Number:

    11-007176

    Who can I contact for additional information about this study?

  6. Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
    Rochester, Minn. View Summary

    Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The Zenith(R) Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft in the treatment of abdominal aortic, aorto-iliac, and iliac aneurysms.

    NCT ID:

    NCT00833924

    Who can I contact for additional information about this study?

    Rochester: Gustavo Oderich, MD 507-255-7208
                        


  7. Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient
    Rochester, Minn. View Summary

    Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

    NCT ID:

    NCT01150097

    Who can I contact for additional information about this study?

    Rochester: Novartis Pharmaceuticals 862-778-8300
                        


  8. Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology
    Rochester, Minn. View Summary

    Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, MN that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

    NCT ID:

    NCT01527344

    IRB Number:

    11-003775

    Who can I contact for additional information about this study?

    Rochester: Rebecca E Nelson 507-288-8388
                        


  9. Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans AIM III
    Rochester, Minn. View Summary

    Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans AIM III

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The main goal of AIM III is to assess and quantify the effect of long-term administration of darapladib 160 mg once a day, a selective, reversible, orally active inhibitor of plasma and vascular Lp-PLA2, on coronary endothelial function, progression of coronary atherosclerosis as determined by IVUS, and atherosclerosis in patients with early atherosclerosis. Patients with evidence of coronary endothelial dysfunction, as determined by intracoronary administration of acetylcholine during angiography and IVUS, will be followed for 6 months during once daily dosing of darapladib. Coronary endothelial function is determined by the changes in coronary artery diameter and coronary blood flow response to the intracoronary administration of acetylcholine and adenosine. The patients will be followed in clinic 6 months. They will have follow-up angiography, assessment of endothelial function, and IVUS during the six month visit.

    NCT ID:

    NCT01067339

    IRB Number:

    10-000044

    Who can I contact for additional information about this study?

    Rochester: Cindy M Woltman, RN 507-266-4095
                        


  10. Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
    Rochester, Minn. View Summary

    Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

    NCT ID:

    NCT01151020

    Who can I contact for additional information about this study?

    Rochester: Gustavo Oderich, MD 507-225-7208
                        


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