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

NCT05836974 | Completed

• 1 other identifier: FSD-BST-2022-08
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Umbilical Cord Blood

Outcome Measures

Primary Outcomes (1)

• Weight of cord blood collection

  have a minimum weight of 85 grams. Subsequently, the efficiency for certain uses will be evaluated: * Biobank for culture media: from 85 to 100 grams * Multicomponent cord blood: \> 100 grams and less than 1.5 billion leukocytes * Transplant: \> 100 grams and greater than 15 billion leukocytes

  At delivery

Secondary Outcomes (7)

• Leukocytes

  At delivery

• Red blood cells

  At delivery

• Hematocrit

  At delivery

• Platelets

  At delivery

• CD34+ cells

  At delivery

Study Arms (2)

Ex-utero cord blood collection

EXPERIMENTAL

Ex-utero cord blood collection

Procedure: Ex-utero cord blood collection

In-utero cord blood collection

ACTIVE COMPARATOR

In-utero cord blood collection

Procedure: In-utero cord blood collection

Interventions

Ex-utero cord blood collection PROCEDURE

SCU units are collected after placental delivery (ex-utero) by trained obstetric personnel. The cord is clamped at one minute postpartum. Once the placenta is expelled, it is rapidly transported to the collection area, which contains supplies and a surgical table designed for ex-utero SCU collection. This table has a top tray supported by an armrest. The placenta is placed on this specially designed tray with a central hole that allows the umbilical cord to hang. Proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol. Subsequently, the umbilical vein is cannulated at the most distal point of the placenta, and placental blood is collected by gravity into a sterile bag. Gentle massage can be applied to the placenta to continue draining blood by gravity. If visible blood remains, a second puncture can be made by bringing the needle insertion point closer to the placenta.

Ex-utero cord blood collection

In-utero cord blood collection PROCEDURE

The cord blood is clamped in a delayed modality, defined as after at least 1 minute after delivery. The cord is sterilized, and cord blood is collected using aseptic technique (proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol). Blood is allowed to flow by gravity and the needle is removed when blood flow ceases.

In-utero cord blood collection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Geographical origin and history of known travels
• Absence of potentially transmissible diseases (infectious, hematological, and autoimmune)
• Absence of diseases that can alter prenatal obstetric variables: multiple pregnancy, pregestational diabetes mellitus, intrauterine growth restriction, hypertensive states of pregnancy or chronic arterial hypertension, and fetal pathology.
• Any type of delivery: vaginal delivery and cesarean section.
• Deliveries from week 37 or higher.
• Standardization of the timing of clamping in all cases to one minute.

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Location

Related Publications (12)

• Querol S, Gomez SG, Pagliuca A, Torrabadella M, Madrigal JA. Quality rather than quantity: the cord blood bank dilemma. Bone Marrow Transplant. 2010 Jun;45(6):970-8. doi: 10.1038/bmt.2010.7. Epub 2010 Mar 1.

  PMID: 20190835 BACKGROUND

• Rocha V, Gluckman E; Eurocord and European Blood and Marrow Transplant Group. Clinical use of umbilical cord blood hematopoietic stem cells. Biol Blood Marrow Transplant. 2006 Jan;12(1 Suppl 1):34-41. doi: 10.1016/j.bbmt.2005.09.006.

  PMID: 16399582 BACKGROUND

• Gluckman E. Milestones in umbilical cord blood transplantation. Blood Rev. 2011 Nov;25(6):255-9. doi: 10.1016/j.blre.2011.06.003. Epub 2011 Jul 20.

  PMID: 21764191 BACKGROUND

• Solves Alcaina P, Perales Marin A, Mirabet Lis V, Brik Spinelli M, Soler Garcia MA, Roig Oltra R. [Donors selection and retrieval of units in an umbilical cord blood bank]. Med Clin (Barc). 2007 Oct 27;129(15):561-5. doi: 10.1157/13111706. Spanish.

  PMID: 17988611 BACKGROUND

• Magalon J, Maiers M, Kurtzberg J, Navarrete C, Rubinstein P, Brown C, Schramm C, Larghero J, Katsahian S, Chabannon C, Picard C, Platz A, Schmidt A, Katz G. Banking or Bankrupting: Strategies for Sustaining the Economic Future of Public Cord Blood Banks. PLoS One. 2015 Dec 1;10(12):e0143440. doi: 10.1371/journal.pone.0143440. eCollection 2015.

  PMID: 26624279 BACKGROUND

• Kurtzberg J, Cairo MS, Fraser JK, Baxter-Lowe L, Cohen G, Carter SL, Kernan NA. Results of the cord blood transplantation (COBLT) study unrelated donor banking program. Transfusion. 2005 Jun;45(6):842-55. doi: 10.1111/j.1537-2995.2005.04428.x.

  PMID: 15934981 BACKGROUND

• Bart T, Boo M, Balabanova S, Fischer Y, Nicoloso G, Foeken L, Oudshoorn M, Passweg J, Tichelli A, Kindler V, Kurtzberg J, Price T, Regan D, Shpall EJ, Schwabe R. Impact of selection of cord blood units from the United States and swiss registries on the cost of banking operations. Transfus Med Hemother. 2013 Feb;40(1):14-20. doi: 10.1159/000345690. Epub 2013 Jan 7.

  PMID: 23637645 BACKGROUND

• Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.

  PMID: 28002310 BACKGROUND

• Lin X, Torrabadella M, Amat L, Gomez S, Azqueta C, Sanchez M, Cuadras D, Martinez Lorenzo MJ, Brull JM, Gaya A, Cemborain A, Perez Garcia C, Arroyo J, Querol S, Gomez Roig MD. Estimated fetal weight percentile as a tool to predict collection of cord blood units with higher cellular content: implications for prenatal selection of cord blood donors. Transfusion. 2018 Jul;58(7):1732-1738. doi: 10.1111/trf.14651. Epub 2018 May 6.

  PMID: 29732577 BACKGROUND

• Vanegas D, Trivino L, Galindo C, Franco L, Salguero G, Camacho B, Perdomo-Arciniegas AM. A new strategy for umbilical cord blood collection developed at the first Colombian public cord blood bank increases total nucleated cell content. Transfusion. 2017 Sep;57(9):2225-2233. doi: 10.1111/trf.14190. Epub 2017 Jun 26.

  PMID: 28653354 BACKGROUND

• Solves P, Moraga R, Saucedo E, Perales A, Soler MA, Larrea L, Mirabet V, Planelles D, Carbonell-Uberos F, Monleon J, Planells T, Guillen M, Andres A, Franco E. Comparison between two strategies for umbilical cord blood collection. Bone Marrow Transplant. 2003 Feb;31(4):269-73. doi: 10.1038/sj.bmt.1703809.

  PMID: 12621461 BACKGROUND

• Solves P, Moraga R, Mirabet V, Larrea L, Soler MA. In utero or ex utero cord blood collection: an unresolved question. Transfusion. 2003 Aug;43(8):1174-6; author reply 1176. doi: 10.1046/j.1537-2995.2003.00459.x. No abstract available.

  PMID: 12869128 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: September 1, 2023
• Primary Completion: June 10, 2024
• Study Completion: September 25, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)