Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01728545
Status:
RECRUITING
Last Update Posted:
2019-05-13
First Post:
2012-11-09
Brief Title:
The Collection and Storage of Umbilical Cord Blood for Transplantation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Collection and Storage of Umbilical Cord Blood for Transplantation
Status:
RECRUITING
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to collect blood samples from the umbilical cords of newborn babies as soon as they are delivered and to place these samples in the MD Anderson Cord Blood Bank Your sample may be included in the National Cord Blood Inventory NCBI which is part of the CW Bill Young Cell Transplantation Program The NCBI is a federally-supported program to assist in the collection of cord blood Cord blood will be made available to patients through The National Marrow Donor Program NMDP These samples may then be offered to MD Anderson and other institutions for patients who need a bone marrow transplant and do not have a donor The MD Anderson Cord Blood Bank will have the rights to release cord blood units to these institutions around the world according to established bone marrow transplant donor criteria for a fee to cover costs
Cord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures If not suitable for patient use or for research purposes the cord blood unit may be thrown away
Cord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures If not suitable for patient use or for research purposes the cord blood unit may be thrown away
Detailed Description:
The blood in an unborn babys umbilical cord contains blood-making cells that could help treat another person with a life-threatening disease These cord blood cells may provide cells for transplants given to patients with marrow diseases such as leukemia These cord blood transplants can be done when a patients cell type human leukocyte antigen or HLA type matches the cord blood type Cord blood is normally thrown away with the umbilical cord and placenta after the baby is born
Collection of the cord blood takes place after your new baby is born and the umbilical cord has been clamped and cut in the normal way The collection of cord blood takes place from the part of the cord that is still connected to the placenta not to your new baby The cord blood may be collected in-utero after your baby is delivered but the placenta is still inside the uterus or it may be collected ex-utero after the placenta is delivered The choice of which method of collection is performed will depend on the preference of your obstetricianmidwife Neither method puts you or your baby at any risk of injury Once the cord blood is drawn it becomes the property of the MD Anderson Cord Blood Bank and you will not retain any residual interests or rights to this sample
During the delivery of your baby your obstetrician has your health and that of your newborn baby as his or her main concern If you agree to take part in this study your doctor andor the Cord Blood Bank staff will try to collect the cord blood but your doctors main concern will be the well being of you and your baby Circumstances may arise which prevent the collection of your cord blood
The cord blood that is collected will be taken to the MD Anderson Cord Blood Bank Laboratory where it will be tested or sent out for testing to laboratories accredited for doing those tests as described below
Just like the donation of blood for transfusion it is important that cord blood does not carry any infections that can be passed on When volunteers donate blood to a blood bank they are asked to fill out a confidential questionnaire about their risks for some infections like acquired immunodeficiency syndrome AIDS caused by the human immunodeficiency virus HIV hepatitis andor malaria You will be asked questions like these in a questionnaire You will also be asked some questions about your family medical history to check for the chance of an inherited disease that could be passed on with the cord blood This questionnaire will be completed within 48 hours of your baby being born and will take about 15 minutes to complete This questionnaire is used for screening purposes and may result in your cord blood not being suitable for patient use in which case the cord blood may be used for research purposes for quality purposes to improve cord blood banking procedures or discarded Your medical chart and that of your infant will be reviewed to help determine whether you may have a disease which could be inherited and thus transmitted with the cord blood to a transplant patient who receives it Additionally you will be asked about your family ethnicracial background this information is used to help match the cord blood to the patients
A blood sample about 2 tablespoonfuls will be drawn from you to test for infectious diseases including HIV human T cell Iymphotrophic virus HTLV Hepatitis B and C cytomegalovirus CMV West Nile Virus WNV Trypanosoma cruzi T cruzi a parasitic organism that causes Chagas disease and syphilis The cord blood unit itself may also be tested for HIV HTLV Hepatitis B and C CMV WNV T cruzi syphilis for bacterial and fungal infection and for the blood type ABORh This testing will be performed at accredited testing laboratories Small samples of your blood and the cord blood about 2 teaspoonfuls each will also be frozen and stored separately to screen for diseases in the future
If you are delivering your baby in Texas as per Texas state law a blood sample will be taken from your baby by the hospital staff and will be sent to the Department of State Health Services to be tested for inherited diseases known as Newborn Screening You will be asked to sign a release form which will allow the Department of State Health Services to release these Newborn screening results to the MD Anderson Cord Blood Bank Since such diseases may be passed on through transplant your donated cord blood unit will not be banked if positive results are received The Department of State Health Services will notify your physician of positive or unclear Newborn screening results
In addition the cord blood unit and sometimes the maternal blood sample will be tested for its HLA type which will be used to identify matches with the transplant patient who needs the cord blood This testing will be performed at MD Anderson A small sample of the cord blood unit will be sent to the Stemcyte and City of Hope Laboratories in California for more sophisticated typing to determine whether the cord blood unit might be useful in treating AIDS patients
Both your blood and your cord blood are tested for infections because there are rare instances where an infection could be found in the mothers blood and yet it has not been found in the cord blood It is also possible although uncommon that an infection could be found in the cord blood but not in the mothers blood If the volume of your donated cord blood is not large enough for banking testing may not be performed
All information you provide as well as the identity of you and your new baby will be kept as confidential as possible to the fullest extent allowed by law While the MD Anderson Cord Blood Bank has to maintain a link between the cord blood unit and information identifying you multiple levels of security will protect this When the information and blood samples are collected they will be given a unique sample number Nobody except the Principal Investigator and those designated by the Principal Investigator will have access to any of your personal information If your cord blood is released to another institution for transplant there will be no way to determine you were the donor as we keep your identity anonymous If your donated cord blood cells are used in a transplant the recipient of your cord blood cells will not be able to access any of your personal information
At the time of donation you will be asked to provide MD Anderson Cord Blood Bank an address for you and your physician If any unclear or positive results are found during the testing of your blood or the cord blood such as HIV HTLV Hepatitis B Hepatitis C WNV Chagas andor syphilis the MD Anderson Cord Blood Bank will notify your physician using the information you have provided to the Cord Blood Bank As required by Texas law a confirmed positive or unclear test for HIVAIDS or syphilis from your blood or the cord blood will be reported to the Texas Department of State Health Services Additionally the Houston Department of Health and Human Services will be notified of any positive West Nile Virus results and they may contact you to conduct a confidential interview to help track community risk to WNV
The Cord Blood Bank may also contact you directly using the contact information you provide in order to obtain updated information about your childs health regarding inherited disorders andor communicable diseases or to request additional information or clarification of information contained in the Cord Blood Bank file If you become aware of any changes in your babys health which may affect the suitability of the donated cord blood unit for transplantation it is important that you contact the Cord Blood Bank at 713-563-8000
The cord blood will be tested and frozen Cord blood units that meet clinical specifications will be stored in the MD Anderson Cord Blood Bank listed on the stem cell donor registries and may be released to MD Anderson or other institutions in the US or around the world following established criteria for bone marrow transplant donors for a fee to cover handling charges These institutions will use the cord blood for patients needing a bone marrow transplant Any fresh or stored cord blood units donated to the Cord Blood Bank that do not meet all the clinical specifications for example if they are too small or have bacterial contamination and cannot be used for patients needing a bone marrow transplant they may be discarded or used for research or in studies to improve the cord blood banking procedures either at MD Anderson or at other institutions Before your cord blood can be used for research the people doing the research must get specific approval from the Institutional Review Board IRB of MD Anderson or the IRB of the institution where the research will be performed The IRB is a committee made up of doctors researchers and members of the community The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner All research performed at MD Anderson including research involving your cord blood from this bank must first be approved by the IRB
The cord blood units will be used on a first come first served basis At the time of donation you will be given the address and phone number of the MD Anderson Cord Blood Bank In the unlikely event that you or another immediate family member develop a disease which would require the use of your donated cord blood it may be released to you on the same basis that it would be provided to other qualifying patients if it is still under the control of the MD Anderson Cord Blood Bank and has not already been committed to a patient You should contact the MD Anderson Cord Blood Bank within one month of collection if you wish to have your donated cord blood unit destroyed If requested the research staff will destroy your cord blood unit if it has not been used for research Cord Blood Bank validation studies or quality control After this one month period has passed your cord blood unit will be made available for patient use and you will be unable to request that it be destroyed
This is an investigational study
Up to 250000 women will take part in this study All will be enrolled through MD Anderson
Collection of the cord blood takes place after your new baby is born and the umbilical cord has been clamped and cut in the normal way The collection of cord blood takes place from the part of the cord that is still connected to the placenta not to your new baby The cord blood may be collected in-utero after your baby is delivered but the placenta is still inside the uterus or it may be collected ex-utero after the placenta is delivered The choice of which method of collection is performed will depend on the preference of your obstetricianmidwife Neither method puts you or your baby at any risk of injury Once the cord blood is drawn it becomes the property of the MD Anderson Cord Blood Bank and you will not retain any residual interests or rights to this sample
During the delivery of your baby your obstetrician has your health and that of your newborn baby as his or her main concern If you agree to take part in this study your doctor andor the Cord Blood Bank staff will try to collect the cord blood but your doctors main concern will be the well being of you and your baby Circumstances may arise which prevent the collection of your cord blood
The cord blood that is collected will be taken to the MD Anderson Cord Blood Bank Laboratory where it will be tested or sent out for testing to laboratories accredited for doing those tests as described below
Just like the donation of blood for transfusion it is important that cord blood does not carry any infections that can be passed on When volunteers donate blood to a blood bank they are asked to fill out a confidential questionnaire about their risks for some infections like acquired immunodeficiency syndrome AIDS caused by the human immunodeficiency virus HIV hepatitis andor malaria You will be asked questions like these in a questionnaire You will also be asked some questions about your family medical history to check for the chance of an inherited disease that could be passed on with the cord blood This questionnaire will be completed within 48 hours of your baby being born and will take about 15 minutes to complete This questionnaire is used for screening purposes and may result in your cord blood not being suitable for patient use in which case the cord blood may be used for research purposes for quality purposes to improve cord blood banking procedures or discarded Your medical chart and that of your infant will be reviewed to help determine whether you may have a disease which could be inherited and thus transmitted with the cord blood to a transplant patient who receives it Additionally you will be asked about your family ethnicracial background this information is used to help match the cord blood to the patients
A blood sample about 2 tablespoonfuls will be drawn from you to test for infectious diseases including HIV human T cell Iymphotrophic virus HTLV Hepatitis B and C cytomegalovirus CMV West Nile Virus WNV Trypanosoma cruzi T cruzi a parasitic organism that causes Chagas disease and syphilis The cord blood unit itself may also be tested for HIV HTLV Hepatitis B and C CMV WNV T cruzi syphilis for bacterial and fungal infection and for the blood type ABORh This testing will be performed at accredited testing laboratories Small samples of your blood and the cord blood about 2 teaspoonfuls each will also be frozen and stored separately to screen for diseases in the future
If you are delivering your baby in Texas as per Texas state law a blood sample will be taken from your baby by the hospital staff and will be sent to the Department of State Health Services to be tested for inherited diseases known as Newborn Screening You will be asked to sign a release form which will allow the Department of State Health Services to release these Newborn screening results to the MD Anderson Cord Blood Bank Since such diseases may be passed on through transplant your donated cord blood unit will not be banked if positive results are received The Department of State Health Services will notify your physician of positive or unclear Newborn screening results
In addition the cord blood unit and sometimes the maternal blood sample will be tested for its HLA type which will be used to identify matches with the transplant patient who needs the cord blood This testing will be performed at MD Anderson A small sample of the cord blood unit will be sent to the Stemcyte and City of Hope Laboratories in California for more sophisticated typing to determine whether the cord blood unit might be useful in treating AIDS patients
Both your blood and your cord blood are tested for infections because there are rare instances where an infection could be found in the mothers blood and yet it has not been found in the cord blood It is also possible although uncommon that an infection could be found in the cord blood but not in the mothers blood If the volume of your donated cord blood is not large enough for banking testing may not be performed
All information you provide as well as the identity of you and your new baby will be kept as confidential as possible to the fullest extent allowed by law While the MD Anderson Cord Blood Bank has to maintain a link between the cord blood unit and information identifying you multiple levels of security will protect this When the information and blood samples are collected they will be given a unique sample number Nobody except the Principal Investigator and those designated by the Principal Investigator will have access to any of your personal information If your cord blood is released to another institution for transplant there will be no way to determine you were the donor as we keep your identity anonymous If your donated cord blood cells are used in a transplant the recipient of your cord blood cells will not be able to access any of your personal information
At the time of donation you will be asked to provide MD Anderson Cord Blood Bank an address for you and your physician If any unclear or positive results are found during the testing of your blood or the cord blood such as HIV HTLV Hepatitis B Hepatitis C WNV Chagas andor syphilis the MD Anderson Cord Blood Bank will notify your physician using the information you have provided to the Cord Blood Bank As required by Texas law a confirmed positive or unclear test for HIVAIDS or syphilis from your blood or the cord blood will be reported to the Texas Department of State Health Services Additionally the Houston Department of Health and Human Services will be notified of any positive West Nile Virus results and they may contact you to conduct a confidential interview to help track community risk to WNV
The Cord Blood Bank may also contact you directly using the contact information you provide in order to obtain updated information about your childs health regarding inherited disorders andor communicable diseases or to request additional information or clarification of information contained in the Cord Blood Bank file If you become aware of any changes in your babys health which may affect the suitability of the donated cord blood unit for transplantation it is important that you contact the Cord Blood Bank at 713-563-8000
The cord blood will be tested and frozen Cord blood units that meet clinical specifications will be stored in the MD Anderson Cord Blood Bank listed on the stem cell donor registries and may be released to MD Anderson or other institutions in the US or around the world following established criteria for bone marrow transplant donors for a fee to cover handling charges These institutions will use the cord blood for patients needing a bone marrow transplant Any fresh or stored cord blood units donated to the Cord Blood Bank that do not meet all the clinical specifications for example if they are too small or have bacterial contamination and cannot be used for patients needing a bone marrow transplant they may be discarded or used for research or in studies to improve the cord blood banking procedures either at MD Anderson or at other institutions Before your cord blood can be used for research the people doing the research must get specific approval from the Institutional Review Board IRB of MD Anderson or the IRB of the institution where the research will be performed The IRB is a committee made up of doctors researchers and members of the community The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner All research performed at MD Anderson including research involving your cord blood from this bank must first be approved by the IRB
The cord blood units will be used on a first come first served basis At the time of donation you will be given the address and phone number of the MD Anderson Cord Blood Bank In the unlikely event that you or another immediate family member develop a disease which would require the use of your donated cord blood it may be released to you on the same basis that it would be provided to other qualifying patients if it is still under the control of the MD Anderson Cord Blood Bank and has not already been committed to a patient You should contact the MD Anderson Cord Blood Bank within one month of collection if you wish to have your donated cord blood unit destroyed If requested the research staff will destroy your cord blood unit if it has not been used for research Cord Blood Bank validation studies or quality control After this one month period has passed your cord blood unit will be made available for patient use and you will be unable to request that it be destroyed
This is an investigational study
Up to 250000 women will take part in this study All will be enrolled through MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA061508 | NIH | None | httpsreporternihgovquickSearchR01CA061508 |