Umbilical Cord BloodNCT05836974
Performance Evaluation of the ex Utero Cord Blood Collection Technique: Procedure, Quality and Results
A study testing Ex-utero cord blood collection and In-utero cord blood collection in people with Umbilical Cord Blood, run by Fundacion Dexeus at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Blood
- What is being tested?
- Ex-utero cord blood collection and In-utero cord blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 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.
Who cannot join
- Pregnant women who meet the exclusion criteria to be cord blood donors.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, 08037
About this study
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.
Read more
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
- Being tested
- Ex-utero cord blood collection, In-utero cord blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-utero cord blood collectionProcedure or surgery
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.
In-utero cord blood collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ex-utero cord blood collection | Experimental | Ex-utero cord blood collection Receives: Procedure: Ex-utero cord blood collection |
| In-utero cord blood collection | Active comparator | In-utero cord blood collection Receives: Procedure: In-utero cord blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At delivery
Secondary outcomes (7)
Leukocytes
(White Blood Cells) : cells/µL
Measured: At delivery
Red blood cells
million/µL
Measured: At delivery
Hematocrit
percentage
Measured: At delivery
Platelets
unit of measurement: cells/µ
Measured: At delivery
CD34+ cells
CD34+ cells are hematopoietic stem cells, meaning cells that can differentiate into various types of blood cells. The amount of CD34+ cells in cord blood is an indicator of the sample's ability to generate new blood cells.
Measured: At delivery
Bacteriology
presence/absence. Bacteriology is the study of bacteria present in a biological sample. In the case of cord blood, a bacteriological analysis is performed to detect the presence of bacteria that may affect the sample's quality.
Measured: At delivery
Hemolysis
presence/absence. Hemolysis is the rupture of red blood cells and the release of their contents into the blood. The presence of hemolysis in cord blood may indicate poor sample quality.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Sep 2023
- Primary completion10 Jun 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimet Caner, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836974
- Sponsor's protocol ID
- FSD-BST-2022-08
- Status last verified
- Oct 2024
- First submitted
- 19 Apr 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20190835Rocha 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.
PubMed 16399582Gluckman 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.
PubMed 21764191Solves 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.
PubMed 17988611Magalon 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.
PubMed 26624279Kurtzberg 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.
PubMed 15934981Bart 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.
PubMed 23637645Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
PubMed 28002310Lin 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.
PubMed 29732577Vanegas 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.
PubMed 28653354Solves 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.
PubMed 12621461Solves 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.
PubMed 12869128Ozbey N, Farssac E, Garcia Martinez S, Castillo N, Rodriguez-Melcon A, Querol S, Fernandez-Sojo J, Prats P. Evaluation of ex-utero collection for umbilical cord blood banking: A randomized clinical trial comparing cord blood quality with the in-utero technique. Int J Gynaecol Obstet. 2026 Jun 4. doi: 10.1002/ijgo.71086. Online ahead of print.
PubMed 42240935
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the ex Utero Cord Blood Collection Technique: Procedure, Quality and Results
- ClinicalTrials.gov ID
- NCT05836974
- Acronym / sponsor ID
- FSD-BST-2022-08
- Conditions
- Umbilical Cord Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex-utero cord blood collection | Experimental | Procedure: Ex-utero cord blood collectionEx-utero cord blood collection |
| In-utero cord blood collection | Active comparator | Procedure: In-utero cord blood collectionIn-utero cord blood collection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 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.
Key exclusion criteria (1 listed)
- Pregnant women who meet the exclusion criteria to be cord blood donors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex-utero cord blood collectionSCU 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. | Procedure or surgery | Ex-utero cord blood collection |
| In-utero cord blood collectionThe 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. | Procedure or surgery | In-utero cord blood collection |
Primary outcome
Weight of cord blood collection
Time frame: At delivery
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
7 secondary outcomes
Leukocytes
Time frame: At delivery
Red blood cells
Time frame: At delivery
Hematocrit
Time frame: At delivery
Platelets
Time frame: At delivery
CD34+ cells
Time frame: At delivery
Bacteriology
Time frame: At delivery
Hemolysis
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 20190835Querol 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.
- Background: PubMed 16399582Rocha 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.
- Background: PubMed 21764191Gluckman 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.
- Background: PubMed 17988611Solves 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.
- Background: PubMed 26624279Magalon 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.
- Background: PubMed 15934981Kurtzberg 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.
- Background: PubMed 23637645Bart 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.
- Background: PubMed 28002310Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
- Background: PubMed 29732577Lin 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.
- Background: PubMed 28653354Vanegas 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.
- Background: PubMed 12621461Solves 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.
- Background: PubMed 12869128Solves 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ex-utero cord blood collection and In-utero cord blood collection in people with Umbilical Cord Blood, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of cord blood collection (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836974, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.