Stem CellsNCT00316069
Stem Cell Collection
An observational study of Stem Cells, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study is designed for the collection of stem cells from the bloodstream for use in research studies. These cells will be studied to determine if they have unique features particular to the donor that may or may not affect their use for developing new treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stem Cells
- How many people
- 429 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2006to 2 Aug 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give informed consent to participate in the protocol.
- Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (including minimum HCT of 28%, platelet count greater than 50,000/uL). Negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1.
- Listed below are acceptable medical conditions for inclusion in this protocol. They are derived from donor criteria that pertain to stem cell mobilization and peripheral blood leukapheresis described by the National Marrow Donor Program. Medical conditions that limit bone marrow harvest or re-infusion of cells into stem cell recipients do not apply to this protocol.
- Age: Volunteers of adult age including those over 60 years old who have no significant cardiovascular disease will be allowed to enroll.
- Allergies: If volunteers suffer from common allergies to animals, the environment, or medications other than G-CSF, they will be allowed to enroll.
- Arthritis: In general, if volunteers have mild to moderate osteoarthritis or degenerative arthritis, they will be allowed to enroll.
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- Cancer: If volunteers have a history of cancer or currently have cancer that does not affect their cardiovascular status, they will be allowed to enroll.
- Mental health conditions: If volunteers have mental health conditions that are well-controlled, they will be allowed to enroll.
- Diabetes: If volunteers have diabetes, a careful evaluation of their current health status will be necessary. In general, if their diabetes is well-controlled by either diet or oral medications, and have no significant cardiovascular disease, they will be allowed to enroll.
Who cannot join
- Any concomitant condition or illness that will result in an inability to undergo G-CSF mobilization or apheresis listed below.
- Allergy to G-CSF or bacterial E. coli products.
- Autoimmune diseases, such as immune thrombocytopenic purpura, rheumatoid arthritis or systemic lupus erythematosus.
- Patients with active pulmonary disease.
- Significant cardiovascular disease or related symptoms such as chest pain, shortness of breath, or uncontrolled hypertension. If volunteers have heart conditions such as well-controlled arrhythmias, or mitral valve prolapse that does not require medication or restrictions, they will be allowed to enroll. If volunteers have elevated blood pressure that is well-controlled by medication or diet and if there is no associated heart disease, they will be allowed to enroll.
- Epilepsy: If volunteers have had more than one seizure in the past year, they will not be allowed to enroll. If volunteers have well-controlled epilepsy and have had no seizures in the past year, they will be allowed to enroll.
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- Active infections.
- Pregnant and lactating women.
- Splenomegaly: Patients having splenic diameters greater than 13.0 cm at the time of initial assessment will be excluded from the protocol.
- Sickle cell disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Peripheral Blood Collection of Adult Stem Cells
This study is designed for the collection of stem cells from the bloodstream for use in research studies. These cells will be studied to determine if they have unique features particular to the donor that may or may not affect their use for developing new treatments.
Volunteers with or without a blood disease may be eligible to donate stem cells for this study. Women who are pregnant or breastfeeding may not enroll.
Read more
Donors are evaluated with a medical history and physical examination, blood tests and an ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis as follows:
Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate release of stem cells from the bone marrow into the bloodstream for collection. On the day of the last injection, donors undergo apheresis to obtain white cells and stem cells. For this procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed into a machine where the white cells and stem cells are separated from the rest of the blood by a spinning process. These cells are extracted and collected in a bag inside the machine, and the rest of the blood is returned to the donor through a second catheter in a vein in the other arm. The procedure takes 4 to 5 hours.
Read the detailed description
Recent advances in the area of stem cell research suggest that redirected differentiation of stem cells may prove useful for the treatment of a variety of diseases including diabetes and other systemic diseases. In the hematopoietic system, recent studies have also demonstrated the ability of adult erythroid stem cells to undergo differentiation toward a fetal-like phenotype. This fetal-like phenotype is crucial in eliminating the clinical sequelae of sickle syndromes and beta hemoglobinopathies. However, additional studies are needed to determine if these results can be applied to patients with diseases involving hematopoietic stem cells or other blood cells. In addition, it is clear that the stem cells from separate donors do not possess identical properties of growth and differentiation.
The immediate aim of this protocol is to obtain hematopoietic stem cells from many human donors for examination of the biological properties of those cells. The study is also designed to determine if the donor-specific factors can influence the properties of their hematopoietic stem cells. Each volunteer will undergo stem cell mobilization after administration of granulocyte-colony stimulating factor (G-CSF) for five consecutive days followed by a large volume apheresis on the 5th day after G-CSF injection. The harvested product will be purified for the primitive hematopoietic progenitor cells and viably preserved in multiple aliquots. The cells will then be studied in-depth for a better understanding of their biological properties, growth and differentiation. Donor-specific information will be correlated with these research studies to identify factors that may assist with the understanding of adult stem cell biology.
- Conditions
- Stem Cells
- Keywords
- Erythropoiesis, Leukapheresis, G-CSF, Mobilization, Stem Cells, Apheresis, Blood Donation, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study start12 Apr 2006
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffery L Miller, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316069
- Sponsor's protocol ID
- 060142
- Other IDs
- 06-DK-0142
- Status last verified
- 2 Aug 2017
- First submitted
- 18 Apr 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Pomerantz J, Blau HM. Nuclear reprogramming: a key to stem cell function in regenerative medicine. Nat Cell Biol. 2004 Sep;6(9):810-6. doi: 10.1038/ncb0904-810.
PubMed 15340448Gershengorn MC, Hardikar AA, Wei C, Geras-Raaka E, Marcus-Samuels B, Raaka BM. Epithelial-to-mesenchymal transition generates proliferative human islet precursor cells. Science. 2004 Dec 24;306(5705):2261-4. doi: 10.1126/science.1101968. Epub 2004 Nov 25.
PubMed 15564314Bhanu NV, Trice TA, Lee YT, Gantt NM, Oneal P, Schwartz JD, Noel P, Miller JL. A sustained and pancellular reversal of gamma-globin gene silencing in adult human erythroid precursor cells. Blood. 2005 Jan 1;105(1):387-93. doi: 10.1182/blood-2004-04-1599. Epub 2004 Sep 14.
PubMed 15367428
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Collection of Adult Stem Cells
- ClinicalTrials.gov ID
- NCT00316069
- Acronym / sponsor ID
- 060142
- Conditions
- Stem Cells
- Keywords
- Erythropoiesis, Leukapheresis, G-CSF, Mobilization, Stem Cells, Apheresis, Blood Donation, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 429 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 12 Apr 2006
- Study completion
- 2 Aug 2017
- First posted
- 19 Apr 2006 (estimated)
- 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.
This study is designed for the collection of stem cells from the bloodstream for use in research studies. These cells will be studied to determine if they have unique features particular to the donor that may or may not affect their use for developing new treatments.
Volunteers with or without a blood disease may be eligible to donate stem cells for this study. Women who are pregnant or breastfeeding may not enroll.
Donors are evaluated with a medical history and physical examination, blood tests and an ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis as follows:
Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate release of stem cells from the bone marrow into the bloodstream for collection. On the day of the last injection, donors undergo apheresis to obtain white cells and stem cells. For this procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed into a machine where the white cells and stem cells are separated from the rest of the blood by a spinning process. These cells are extracted and collected in a bag inside the machine, and the rest of the blood is returned to the donor through a second catheter in a vein in the other arm. The procedure takes 4 to 5 hours.
Detailed description
Recent advances in the area of stem cell research suggest that redirected differentiation of stem cells may prove useful for the treatment of a variety of diseases including diabetes and other systemic diseases. In the hematopoietic system, recent studies have also demonstrated the ability of adult erythroid stem cells to undergo differentiation toward a fetal-like phenotype. This fetal-like phenotype is crucial in eliminating the clinical sequelae of sickle syndromes and beta hemoglobinopathies. However, additional studies are needed to determine if these results can be applied to patients with diseases involving hematopoietic stem cells or other blood cells. In addition, it is clear that the stem cells from separate donors do not possess identical properties of growth and differentiation.
The immediate aim of this protocol is to obtain hematopoietic stem cells from many human donors for examination of the biological properties of those cells. The study is also designed to determine if the donor-specific factors can influence the properties of their hematopoietic stem cells. Each volunteer will undergo stem cell mobilization after administration of granulocyte-colony stimulating factor (G-CSF) for five consecutive days followed by a large volume apheresis on the 5th day after G-CSF injection. The harvested product will be purified for the primitive hematopoietic progenitor cells and viably preserved in multiple aliquots. The cells will then be studied in-depth for a better understanding of their biological properties, growth and differentiation. Donor-specific information will be correlated with these research studies to identify factors that may assist with the understanding of adult stem cell biology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to give informed consent to participate in the protocol.
- Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (including minimum HCT of 28%, platelet count greater than 50,000/uL). Negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1.
- Listed below are acceptable medical conditions for inclusion in this protocol. They are derived from donor criteria that pertain to stem cell mobilization and peripheral blood leukapheresis described by the National Marrow Donor Program. Medical conditions that limit bone marrow harvest or re-infusion of cells into stem cell recipients do not apply to this protocol.
- Age: Volunteers of adult age including those over 60 years old who have no significant cardiovascular disease will be allowed to enroll.
- Allergies: If volunteers suffer from common allergies to animals, the environment, or medications other than G-CSF, they will be allowed to enroll.
Key exclusion criteria (10 listed)
- Any concomitant condition or illness that will result in an inability to undergo G-CSF mobilization or apheresis listed below.
- Allergy to G-CSF or bacterial E. coli products.
- Autoimmune diseases, such as immune thrombocytopenic purpura, rheumatoid arthritis or systemic lupus erythematosus.
- Patients with active pulmonary disease.
- Significant cardiovascular disease or related symptoms such as chest pain, shortness of breath, or uncontrolled hypertension. If volunteers have heart conditions such as well-controlled arrhythmias, or mitral valve prolapse that does not require medication or restrictions, they will be allowed to enroll. If volunteers have elevated blood pressure that is well-controlled by medication or diet and if there is no associated heart disease, they will be allowed to enroll.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 15340448Pomerantz J, Blau HM. Nuclear reprogramming: a key to stem cell function in regenerative medicine. Nat Cell Biol. 2004 Sep;6(9):810-6. doi: 10.1038/ncb0904-810.
- Background: PubMed 15564314Gershengorn MC, Hardikar AA, Wei C, Geras-Raaka E, Marcus-Samuels B, Raaka BM. Epithelial-to-mesenchymal transition generates proliferative human islet precursor cells. Science. 2004 Dec 24;306(5705):2261-4. doi: 10.1126/science.1101968. Epub 2004 Nov 25.
- Background: PubMed 15367428Bhanu NV, Trice TA, Lee YT, Gantt NM, Oneal P, Schwartz JD, Noel P, Miller JL. A sustained and pancellular reversal of gamma-globin gene silencing in adult human erythroid precursor cells. Blood. 2005 Jan 1;105(1):387-93. doi: 10.1182/blood-2004-04-1599. Epub 2004 Sep 14.
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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.
Jeffery L Miller, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cells, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 United States. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316069, which also lists 3 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 17 Dec 2019.