A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Date Added
July 3rd, 2012
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered "investigational" products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner

List of Studies


Keywords
Urinary
Summary

Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI [25]. On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Date Added
June 22nd, 2012
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children's Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Clinical Database for Rehabilitation Research after Neurological Injury

Date Added
May 7th, 2012
PRO Number
Pro00015991
Researcher
Steven Kautz

List of Studies


Keywords
Healthy Volunteer Studies, Rehabilitation Studies, Spinal Cord, Stroke
Summary

In this study researchers aim to improve the collaborative research efforts of the Center for Rehabilitation Research in Neurological Conditions at the Medical University of South Carolina. The Center is comprised of several laboratories, including: the Communication and Swallowing Laboratory; the Locomotor Energetics and Assessment Laboratory; the Locomotor Rehabilitation Laboratory; the Neuromuscular Assessment Laboratory; and the Upper Extremity Motor Function Laboratory. The PI and investigators will recruit for their current and future studies in the above laboratories from the Clinical Database established here. Studies utilizing the Clinical Database will not include PHI but will only link to the Clinical Database individual patient code. This study is completed by completing a simple screening form with study personnel. Medical care/treatment future participation in studies is not influenced by inclusion in this study. We are also recruiting Healthy Controls for this study.

Institution
MUSC
Recruitment Contact
Aaron Embry
843-792-8198
embry@musc.edu

Language Development in Teens and Young Adults with Fragile X Syndrome or Autism

Date Added
January 25th, 2012
PRO Number
Pro00014212
Researcher
Jessica Klusek

List of Studies

Keywords
Adolescents, Autism, Healthy Volunteer Studies, Language
Summary

We are recruiting mothers of children with typical development, autism, or fragile X syndrome.

This study focuses on parental experiences and normal individual differences that may influence child language development. The broader goal of the study is to understand which family experiences support language development in children who have neurodevelopmental disabilities, such as autism. We are recruiting families who have children who are typically developing, have autism, or have fragile X syndrome.

Institution
USC
Recruitment Contact
Jessica Klusek
803 777 5676
klusek@mailbox.sc.edu

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Date Added
January 10th, 2012
PRO Number
Pro00015069
Researcher
Megan Ruppel

List of Studies

Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Human Aortic Tissue Analysis in Health and Disease

Date Added
June 17th, 2008
PRO Number
Pro00125518
Researcher
Jeffrey Jones

List of Studies


Keywords
Cardiovascular
Summary

Patients diagnosed with an enlarged aorta (aneurysm) or separation of the layers of the aorta (dissection) can suffer complications. The purpose of this study is to determine the levels of proteins and their effects on the aortic tissue wall.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
8438765049
wakefila@musc.edu

Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Date Added
December 17th, 2002
PRO Number
Pro00136123
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Transplant
Summary

The Center for International Blood and Marrow Transplant Research (CIBMTR ) keeps a research database. It uses this database to collect and study the medical data for patients that have received Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries. It also collects and studies data from donors who give bone marrow or peripheral blood stem cells (PBSCs). These therapies are used to treat cancer and other diseases. The purpose of this study is to add more data to the database. Participants will have medical data (data about their disease, transplant or cellular therapy) collected before and after transplant cellular therapy, and once a year afterwards for life.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Date Added
December 17th, 2002
PRO Number
Pro00136076
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Transplant
Summary

The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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