When hematopoietic stem cell transplant (HSCT) is necessary for children with acute myeloid leukemia (AML), there remains debate about the best stem cell source. (duke.edu)
UCB, a source of hematopoietic stem cells (HSCs), has garnered attention from scientific and medical communities since its first successful use in a hematopoietic stem cell transplant (HSCT) in 1988. (asu.edu)
Neutrophil recovery6
On April 17, the U.S. Food and Drug Administration (FDA) approved omidubicel-onlv (Omisirge) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. (ascopost.com)
The main efficacy outcome measures were time to neutrophil recovery following transplantation and the incidence of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) grade 2/3 bacterial or grade 3 fungal infections through day 100 posttransplantation. (ascopost.com)
The median time to neutrophil recovery was 12 days for those receiving omidubicel-onlv (95% confidence interval [CI] = 10-15 days) and 22 days in the UCB arm (95% CI = 19-25 days). (ascopost.com)
Eighty-seven percent of patients in the omidubicel-onlv arm and 83% percent in the UCB arm achieved neutrophil recovery. (ascopost.com)
The main measured outcomes were based on neutrophil recovery time after transplantation, and blood/marrow bacterial or fungal infections through day 100 after transplant. (healthtree.org)
The median neutrophil recovery for UCB patients was 22 days. (healthtree.org)
Transplantation in Children2
Factors Associated with Long-Term Risk of Relapse after Unrelated Cord Blood Transplantation in Children with Acute Lymphoblastic Leukemia in Remission. (duke.edu)
The population was restricted to patients with high-risk hematologic malignancy, the most common indication of UCB transplantation in children. (nih.gov)
Graft7
Similar to approved UCB products, the prescribing information contains a Boxed Warning for fatal or life-threatening infusion reactions, graft-vs-host disease (GVHD), engraftment syndrome, and graft failure. (ascopost.com)
UCB also has greater tolerance of HLA disparity with lower risk of graft-versus-host disease (GVD). (sajbl.org.za)
Transplantation with omidubicel provides faster neutrophil and platelet recovery compared with a standard umbilical cord blood graft. (healthtree.org)
Abstract Background In the setting of allogeneic human leukocyte antigen (HLA)-matched bone marrow transplantation, transplanting male patients with grafts from female donors has been associated with a higher incidence of graft-versus-host disease (GVHD) and of nonrelapse mortality (NRM). (uab.cat)
Increasing the number of hematopoietic stem and progenitor cells within an umbilical cord blood (UCB) graft shortens the time to hematopoietic recovery after UCB transplantation. (duke.edu)
As compared with stem-cell grafts from adult donors, cord blood has the advantages of more rapid availability, relative absence of donor attrition, and, after transplantation, a reduced risk of graft-versus-host disease (GVHD). (nih.gov)
For this reason, various strategies have been explored to increase the number of hematopoietic stem cells in a cord-blood graft, including the infusion of two cord-blood units from different partially HLA-matched donors. (nih.gov)
UCBT2
For pediatric patients with acute lymphoblastic leukemia (ALL), relapse is an important cause of treatment failure after unrelated cord blood transplant (UCBT). (duke.edu)
The use of umbilical cord blood (UCB) has been steadily increasing, and UCB transplantation (UCBT) currently accounts for one-third of all allogeneic HCTs. (apbmt.org)
Autologous3
Allogeneic HCT has been widely used, while autologous HCT, which is still useful, is less prevalent because of concerns around post-transplant relapse, as well as the recently extended application of allogeneic HCT. (apbmt.org)
Duke University has conducted multiple clinical trials investigating the use of both autologous and allogeneic umbilical cord blood (UCB) in the treatment of cerebral palsy ( NCT01147653 , NCT02599207 ) and autism spectrum disorder ( NCT02847182 ). (upstatecordbloodbank.com)
As stated in the new open access clinical trial, "The use of (UCB) in this fashion is based on safety and efficacy data from prior and ongoing clinical trials at Duke University Medical Center in over 700 patients with these diagnoses infused with autologous or sibling UCB over the past decade. (upstatecordbloodbank.com)
Allogeneic2
The Hematopoietic Cell Transplant Comorbidity Index predicts survival after allogeneic transplant for nonmalignant diseases. (duke.edu)
The 5-year probability of overall survival (OS) after allogeneic HCT was estimated to be 56% (95% confidence interval[CI], 55%- 57%) for patients receiving a transplant while in CR, and 22% (95% CI, 21%-23%) for those who were experiencing active disease. (apbmt.org)
The organizers designed this workshop in the context of the ongoing research project "The public debate on umbilical cord blood banking in Greece: Approaches from the interdisciplinary field Science, Technology, Society (STS)", funded by the Onassis Foundation (Special Grant and Support Program for Scholars' Association Members) and hosted by the Department of History and Philosophy of Science, School of Science, National and Kapodistrian University of Athens). (easst.net)
The design of the workshop served the purpose of bringing together scholars working on umbilical cord blood (UCB) biobanking and the STS/HTS research community working on broader themes regarding biotechnology and medical technologies. (easst.net)
Recent medical advances in the field of regenerative medicine and tissue transplantation have highlighted the importance of umbilical cord blood (UCB) as a valuable alternative source of haematopoietic stem cells, which are potentially life-saving in a vast array of clinical applications. (sajbl.org.za)
Currently only private umbilical cord banking is practised in South Africa and the regulatory framework for human tissue use is still rudimentary with no clear guidelines. (sajbl.org.za)
In the novel and exciting field of regenerative medicine, umbilical cord blood (UCB), also known as placental blood, is no longer considered biological waste. (sajbl.org.za)
For more than 30 years, umbilical cord blood (UCB) has been an important stem cell source for patients with leukemia, lymphoma and MDS. (healthtree.org)
This approval was based on a Phase 3 trial study ( NCT02730299 ) where the safety and efficacy of omidubicel and umbilical cord blood were tested. (healthtree.org)
To determine whether two partially HLA-matched umbilical cord-blood (UCB) units were better than one at improving one-year survival in pediatric patients with high risk leukemia or myelodysplasia. (nih.gov)
Once regarded as medical waste, the umbilical cord has become a source of lifesaving treatment. (asu.edu)
Safety and efficacy2
Safety and efficacy were evaluated in Study P0501 (ClinicalTrials.gov identifier NCT02730299 ), an open-label, multicenter, randomized trial of omidubicel-onlv transplantation or unmanipulated cord blood (UCB) unit transplantation following myeloablative conditioning in patients with hematologic malignancies. (ascopost.com)
A pilot study evaluating the safety and efficacy of double-unit cord-blood transplantation was performed, with promising results. (nih.gov)
Regenerative2
In view of the fact that UCB has become a valuable, non-invasive source of stem cells for regenerative therapy, establishment of a public cord blood bank (CBB) in South Africa would vastly improve the availability of haematopoietic stem cells for research and therapeutic uses, and increase the tissue genetic diversity that currently impedes the South African bone marrow registry. (sajbl.org.za)
The authors found that, out of 94,803 respondent families, 4.23% reported at least one child with an indication for regenerative therapy with cord blood. (upstatecordbloodbank.com)
Donors2
This environment raises ethical questions about consent and ownership of tissues, the cost-effectiveness of harvesting and storage of UCB, undue influence on donors, and issues of distributive justice such as the fact that UCB, which is potentially life-saving and could be easily obtained, may become a resource unfairly restricted only to the wealthy. (sajbl.org.za)
The use of fresh platelet units for the production of PL raises concerns due to limited availability of platelet donors. (biomedcentral.com)
Bone6
2 , 3 Normally, the bone marrow serves as the source for replenishing the cellular components of peripheral blood including red and white blood cells and platelets. (sajbl.org.za)
UCB may also be used to reconstitute the bone marrow after high-dose chemotherapy or radiotherapy. (sajbl.org.za)
Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of cells capable of both homing to the bone marrow and regenerating a full array of cell lineages with early and late repopulating ability in a timely fashion. (healthtree.org)
The number of related HCTs has remained stable, while the use of peripheral blood stem cells (PBSCs) has now largely replaced that of bone marrow (BM). (apbmt.org)
Till's work with stem cells in bone marrow, which produces the body's blood cells, helped form the field of modern hematology, a medical discipline that focuses on diseases related to the blood. (asu.edu)
However, transplanting other than hematopoietic stem and progenitor cells is still limited to a few applications, and it mainly applies to mesenchymal stromal cells (MSCs) isolated from bone marrow. (hindawi.com)
Stem cell source1
The influence of stem cell source on transplant outcomes for pediatric patients with acute myeloid leukemia. (duke.edu)
Outcomes1
The aim of the current analysis was to compare transplantation outcomes in male patients given female unrelated cord blood (UCB) versus other gender combinations. (uab.cat)
Median2
Fifty-two patients were transplanted with omidubicel-onlv receiving a median CD34+ cell dose of 9.0 × 10 6 cells/kg (range = 2.1-47.6 × 10 6 cells/kg). (ascopost.com)
The median number of infused total nucleated cells per kilogram was 7.2×107 for recipients of double-unit grafts and 3.9×107 for recipients of single-unit grafts. (nih.gov)
Clinical8
As a source of non-embryonic stem cells, UCB has found potential uses as a therapeutic modality in more than 80 clinical applications, both haematological and non-haematological. (sajbl.org.za)
Expired units might represent an alternative, but further data are needed to define safety, including pathogen reduction, and functionality of the obtained PL. In addition, relevant questions concerning the definition of PL release criteria, including concentration ranges of specific growth factors in PL batches for various clinical indications, also need to be addressed. (biomedcentral.com)
Today, over 80 diseases have been treated with cord blood stem cells because of ongoing cord blood research and clinical trials! (upstatecordbloodbank.com)
Duke University Medical Center has received permission from the FDA to offer cord blood therapy for conditions like autism spectrum disorder and cerebral palsy under an expanded access clinical trial. (upstatecordbloodbank.com)
This protocol establishes an umbrella clinical trial NCT03327467 registered on 31 Oct. 2017 which enables children who have these neurological disorders to receive therapy with their own cord blood or cord blood from a sibling, regardless of whether they qualify for a targeted clinical trial. (upstatecordbloodbank.com)
The registration of this clinical trial is a watershed moment, opening the door for many children who are afflicted with an acquired neurological disorder to travel to Duke University for cord blood therapy, provided they have a suffienctly matching cord blood unit in a family bank. (upstatecordbloodbank.com)
However, in order to be eligible to participate in the new clinical trial, patients must have their own or a sibling's cord blood preserved in a family bank. (upstatecordbloodbank.com)
Breaking News: The Cord Blood Association (CBA) announces 13 Nov. 2017 they are seeking funds to convert this protocol into a multi-center clinical trial administered by CBA and Duke. (upstatecordbloodbank.com)
Survival2
Results In comparison with other gender combination, male patients given female UCB (n = 131) had a trend for a higher incidence of grades II-IV acute GVHD (33 versus 25 %, P = 0.08), a trend for a higher incidence of NRM (41 versus 33 %, P = 0.06), and a lower leukemia-free (LFS, 30 versus 41 %, P = 0.01) and overall survival (OS, 33 versus 45 %, P = 0.008). (uab.cat)
and lower survival inmale patients transplanted with female unrelated cord blood - A report from Eurocord, the Acute Leukemia Working Party, and the Cord Blood Comm. (uab.cat)
Patients12
In total, 125 patients were randomly assigned: 62 patients to receive omidubicel-onlv and 63 to the UCB group. (ascopost.com)
Fifty-six patients were transplanted in the UCB arm with one or two cord units (66% received two cord units). (ascopost.com)
UCB has increased access to transplantation for patients who can not find an exact stem cell match. (healthtree.org)
Patients and methods Data from 552 consecutive patients with acute myeloid leukemia (AML) given a single UCB transplantation between 2000 and 2014 were included. (uab.cat)
Conclusions Our data suggest that male patients transplanted with female UCB might have higher risk of acute GVHD and of NRM leading to worse LFS and OS. (uab.cat)
These results should be confirmed in other large cohorts of patients before used for determining the choice of an UCB unit. (uab.cat)
113 patients were randomly assigned to receive a single-unit transplant, with 112 undergoing transplantation (1 did not proceed to the transplantation stage). (nih.gov)
One patient randomly assigned to receive a double-unit transplant and 2 patients randomly assigned to receive a single-unit transplant crossed over to the other treatment group. (nih.gov)
Patients were treated with 75 mg of fludarabine per square meter of body-surface area, 1320 cGy of total-body irradiation, and 120 mg of cyclophosphamide per kilogram, followed by the infusion of one or two cord-blood units. (nih.gov)
This expanded access protocol is a triple win for patients, family cord blood banks, and Duke University Medical Center. (upstatecordbloodbank.com)
In the United States alone, there are over a million cord blood units in family storage , so that if 2% of the inventory corresponds to children with eligible conditions, that potentially translates into 20,000 patients. (upstatecordbloodbank.com)
Including cancers1
Deficiency or malfunction of these blood cells occurs in disease conditions prevalent in Africa, including cancers like leukaemia and haemoglobinopathies like thalassaemia or sickle-cell disease. (sajbl.org.za)
Nicotinamide1
Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo With Nicotinamide. (duke.edu)
Omidubicel (NiCord®) "is a patient-specific cell product derived from a single banked UCB unit. (healthtree.org)
99% of the UCBTs were performed using a single UCB unit. (apbmt.org)
However, the limited number of hematopoietic cells in a single cord-blood unit prevents its use in recipients with larger body mass and results in delayed hematopoietic recovery and higher mortality. (nih.gov)
Platelet1
When using UCB, the low number of stem cells compromises the chances of successful engraftment and can delay the neutrophil and platelet recovery. (healthtree.org)
Research2
2 UCB is at the forefront of research exploring gene therapy, prenatal diagnosis, immune cell therapy, antibiotic efficacy and identification of new proteins. (sajbl.org.za)
Department Purpose This position is one of three senior veterinarians that support Campus Veterinary Services (CVS), a unit that provides routine veterinary care and project support for most research and teaching animals on and off campus. (aalas.org)
Risk1
The use of fetal bovine serum (FBS) as a cell culture supplement is discouraged by regulatory authorities to limit the risk of zoonoses and xenogeneic immune reactions in the transplanted host. (biomedcentral.com)
Cells5
Although less controversial than the use of embryonic stem cells obtained from fetal tissue, the practice of UCB biobanking presents several ethical and regulatory challenges surrounding its procurement and use, especially in developing countries like South Africa, where the majority of the population is vulnerable and prone to exploitation. (sajbl.org.za)
In 1983 Koike 7 showed that UCB-derived stem cells could be frozen and stored for future use. (sajbl.org.za)
At cryopreservation, the primary unit had to contain at least 2.5×107 nucleated cells per kilogram of the recipient's actual body weight, with the second unit containing at least 1.5×107 nucleated cells per kilogram of body weight. (nih.gov)
Absolute numbers of CD4+, CD8+, CD19+, and CD16/CD56+ cells were determined on days 100, 180, and 365 after cord-blood transplantation. (nih.gov)
Each participating center is required to register all consecutive HCTs, report core information for registered HCTs as of post-transplant day 100, and report follow-up information annually. (apbmt.org)