Collection of Samples and Data for the National Marrow Donor Program Repository

01:27 EDT 21st October 2014 | BioPortfolio

Summary

This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the Research Database Program and the Research Sample Repository.

Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study.

Participants in the NMDP Research Database program will have medical information about their disease and their transplant sent to the NMDP before and after the transplant and once a year for the rest of their life. The information will be used to help determine how well transplant recipients recover from their transplant, how recovery after a transplant can be improved, how access to transplant for different groups of patients can be improved and how well donors recover from collection procedures.

Participants in the NMDP Research Sample Repository program will have a small blood sample drawn from a vein in the arm just before they start taking medicines for the conditioning regimen to prepare them for the transplant. The blood samples will be used to look at ways to improve how patients are matched with their donors, to determine and evaluate the factors that affect transplant outcome, and to help develop methods to improve tissue matching between donors and recipients.

Description

The National Institutes of Health (NIH) has entered into a Transplant Center Participation Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH investigator with an NIH Institutional Review Board (IRB) approved protocol to secure hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the purpose of transplanting patients who have no suitable matched related donors. As part of this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as baseline and outcome data (mainly demographic, quality of life, and clinical data) be collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated donor HSC transplantation for both the donors and recipients, and to have a comprehensive source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR is the sole custodian of the data in the Research Database.

The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) level data submission for NIAID Allogeneic recipient patients and their donors. This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer.

Study Design

Time Perspective: Prospective

Conditions

Hematopoietic Stem Cell Transplantation

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Clinical Trials [1701 Associated Clinical Trials listed on BioPortfolio]

Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

The objectives of this study are as follows: To demonstrate the safety of escalating doses of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantat...

Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

The purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem cell transplantation is able to induce prolonged and significant increases of C-peptide levels a...

Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy

Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endoth...

Hematopoietic Stem Cell Transplantation (HCT) for Inborn Errors of Metabolism

The primary objective of this clinical trial is to evaluate the ability to achieve and sustain donor engraftment in patients with lysosomal and peroxisomal inborn errors of metabolism unde...

Nutrition Support in Pediatric Stem Cell Transplantation

The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children...

PubMed Articles [19408 Associated PubMed Articles listed on BioPortfolio]

Effects of Targeted Education for First-Year University Students on Knowledge and Attitudes About Stem Cell Transplantation and Donation.

Hematopoietic stem cell transplantation is a life-saving treatment, but donor numbers are lacking in Turkey and elsewhere. Increased awareness of hematopoietic stem cell transplantation among universi...

Children's lived experiences of hematopoietic stem cell transplantation.

Although hematopoietic stem cell transplantation is a valuable treatment in many life-threatening pediatric disorders, a large number of children who receive hematopoietic stem cell transplantation ar...

Antimicrobial prophylaxis in hematopoietic stem cell transplantation recipients: 10 years after.

Antimicrobial prophylaxis is recommended for all patients undergoing hematopoietic stem cell transplantation. Evidence-based guidelines recently have been updated to incorporate the results from recen...

Skeletal Muscle-derived Hematopoietic Stem Cells: Muscular Dystrophy Therapy by Bone Marrow Transplantation.

For postnatal growth and regeneration of skeletal muscle, satellite cells, a self-renewing pool of muscle stem cells, give rise to daughter myogenic precursor cells that contribute to the formation of...

Neuromuscular complications after hematopoietic stem cell transplantation.

The aim of this study was to analyze the occurrence of neuromuscular symptoms in recipients of allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of malignant hematopoietic diseas...

Medical and Biotech [MESH] Definitions

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

The release of stem cells from the bone marrow into the peripheral blood circulation for the purpose of leukapheresis, prior to stem cell transplantation. Hematopoietic growth factors or chemotherapeutic agents often are used to stimulate the mobilization.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Transplantation of stem cells collected from the peripheral blood. It is a less invasive alternative to direct marrow harvesting of hematopoietic stem cells. Enrichment of stem cells in peripheral blood can be achieved by inducing mobilization of stem cells from the BONE MARROW.

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