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: Julia M Thebiay 507-538-8425
                        


  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: ALS Study Team 507-284-2676
                        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. PRESERVE-Zenith® Iliac Branch Clinical Study

    Phoenix/Scottsdale, Ariz. View Summary

    PRESERVE-Zenith® Iliac Branch Clinical Study

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The PRESERVE-Zenith® Iliac Branch Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™/Atrium iCAST™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

    NCT ID:

    NCT01208415

    IRB Number:

    14-003181

    Who can I contact for additional information about this study?

    Rochester: Gustavo Oderich, MD 507-284-1575
                        


  5. Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study

    Jacksonville, Fla. View Summary

    Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

    NCT ID:

    NCT01931007

    IRB Number:

    12-004459

    Who can I contact for additional information about this study?

  6. 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?

  7. MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Phoenix/Scottsdale, Ariz. View Summary

    MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

    NCT ID:

    NCT01670981

    IRB Number:

    13-001455

    Who can I contact for additional information about this study?

    Rochester: Bola Aduloju, RN 507-255-2831
                        Cindy M. Woltman, RN 507-266-4095
    Scottsdale: Barbara Knight 480-342-2545
                        
    Jacksonville: Estela Staggs 904-953-8509
                        
  8. 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® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat 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
                        


  9. 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
                        


  10. 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
                        


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