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Umbilical Cord Blood clinical trials

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NCT ID: NCT05836974 Recruiting - Clinical trials for Umbilical Cord Blood

Performance Evaluation of the ex Utero Cord Blood Collection Technique: Procedure, Quality and Results

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Umbilical cord blood (UCB) is used for leukemia patients and other serious blood disorders worldwide. (3) It has also been recently used for other therapeutic applications such as wound treatment, red blood cell transfusion, or cellular or regenerative therapy. Until now, cord blood banks have worked to have many units in reserve to offer maximum compatibility with patients. The priority is to increase the quality of cord blood by collecting units that have more stem cells with less contamination so that more patients can benefit, that is, improving the efficiency of the process. The conventional in utero technique allowed for a more rapid diffusion of cord blood donation programs as it does not require accessories or additional personnel to carry it out. The UCB donation program was initiated in Catalonia in 1995, and since then, this has been the technique used (www.bancsang.net/info-corporativa/qui-som). Some comparisons have been made in the scientific literature with the results found . Currently, there are some new applications of UCB that require its use in fresh form, and it would be beneficial to minimize the risk of bacterial contamination that seems to be reduced with ex utero collection. Therefore, the proposition for this study is to confirm equivalence in quality characteristics and create opportunities for its extensive application. Currently, cord blood donation is offered to all expectant mothers, provided that the donor does not have any medical exclusion. A very small number of the collected units are suitable for clinical use once processed, making donation programs truly inefficient. This inefficiency generates a workload and waste of public resources that are limited and can also cause ethical dilemmas. Therefore, new strategies are needed to increase the efficiency of donation programs. The Blood and Tissue Bank (BST) has an efficiency improvement study underway using the ex-utero collection technique. The development of this methodology will allow later to propose expanded collection methods, such as the simultaneous collection of cord blood and placenta. The update of new protocols in childbirth care encourages to explore new systematic umbilical cord blood collection methods with the following objectives: to intervene less in the delivery room obtaining products of equal quality and less contamination and to facilitate the simultaneous donation of UCB and placenta in the future. To ensure that the units have maximum quality, both cellular and free of bacteriology, and can be used safely, the investigators propose the implementation of ex utero cord blood collection. The ex-utero UCB collection involves minimal manipulation, allowing for better cord asepsis. After the birth of the baby and cord clamping at one minute, the investigators wait for the delivery of the placenta and proceed to obtain the ex-utero UCB sample. Thanks to this technique, residual cord blood can be obtained, and the placenta can be collected simultaneously, maintaining the same volume as in in utero collection and reducing contamination and hemolysis of the samples. This technique poses no risk to either the mother or the baby. The ex-utero cord blood collection technique is a validated technique used in different studies. To verify these data in our environment and propose a change in the cord blood collection strategy in public banks, this study has been designed. If the investigators demonstrate that this methodology meets quality objectives, similar to the in-utero technique but significantly reducing associated contamination from the delivery field and the presence of hemolysis, the cord blood bank can implement this new systematic method in centers with highly trained collection personnel, releasing obstetric professionals from their intervention in the delivery room and favoring better quality of the products obtained.

NCT ID: NCT04594031 Withdrawn - Sickle Cell Disease Clinical Trials

US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease

Start date: July 13, 2021
Phase: Phase 1
Study type: Interventional

The application of experimental hematopoietic cell transplantation (HCT) therapy in sickle-cell disease (SCD) must strike a balance between the underlying disease severity and the possibility of a direct benefit of the treatment, particularly in pediatric populations. Clinical studies in adults with SCD have focused on interventions that prolong survival and improve the quality of life. Unlike children, adults with SCD are much more likely to have a debilitating complication. As a result, the risk/benefit ratio of HCT is very favorable in adults, particularly if an approach to HCT that defines an acceptable level of toxicity can be established. Whereas hematopoietic stem cell transplantation (HSCT) remains the only curative treatment currently available for patients with SCD, the morbidity, the frequent irreversible damage in target organs and the mortality reported in the natural course of patients with severe SCD are strong incentives to perform HSCTs in younger age groups. For those who lack a matched related donor, CB transplant is an appealing option, but despite been less problematic, CB accessibility related to cell dose of appropriately matched cord blood unit (CBU) remains a significant issue. Through a 7-day culture process of a CBU's hematopoietic stem cell HSCs with the UM171 compound, the total cell dose is increased mitigating this limitation. UM171-CB expansion (ECT-001-CB) allows a greater CB accessibility, the selection of better matched cords that might translate into favourable clinical outcomes as reported in previous trials, including a lower risk of graft-versus-host disease. After CB selection and ex-vivo expansion, ECT-001-CB transplant will follow a myeloablative reduced-toxicity conditioning regimen consisting of rATG, busulfan and fludarabine with doses of all agents optimized to the individual using model-based dosing and will be followed by standard supportive care and GVHD prophylaxis consisting of tacrolimus and MMF.

NCT ID: NCT04420494 Recruiting - Clinical trials for Umbilical Cord Blood

Umbilical Cord Blood Treatment for Refractory Immune Cytopenia

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

Immune-related hematocytopenia is a type of immunity Inflammatory cytopenia-mediated diseases, hormones and immunosuppressants are its first-line treatment. However, conventional immunosuppressants are ineffective or have a high recurrence rate. And some patients are not effective for these treatments, due to infection of blood cells, bleeding, decreased quality of life, and even severe death. There is currently no effective method for such patients. This study intends to recruit IRIC patients, give cord blood infusion, observe its efficacy and safety, and detect changes in inflammation-related indicators before and after treatment. There are no relevant reports at China and abroad. This study can provide new treatment options for patients with IRIC.

NCT ID: NCT04013646 Recruiting - Stroke Clinical Trials

Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

Start date: May 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.

NCT ID: NCT01763099 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the utility of treating patients experiencing graft failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined with cord blood. The first objective of this study was to evaluate the effect of such treatment on graft failure, and second object was to investigate the safety of such treatment.

NCT ID: NCT01235468 Withdrawn - Clinical trials for Hematological Malignancies

Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.