Anemia, AplasticPhase 2NCT00000603
Cord Blood Stem Cell Transplantation Study (COBLT)
A Phase 2 study testing stem cell transplantation in people with Anemia, Aplastic and Fanconi Anemia, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Anemia, Aplastic, Fanconi Anemia, Hematologic Diseases
- What is being tested?
- stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1996to Oct 2007
- Phase
- Phase 2
- 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 Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Mothers of Infant-donors must complete a medical history form, have an uncomplicated delivery, and deliver at UCLA or Duke.
Patients are those who need a transplant but don't have a matched marrow donor or can't wait to find one.
About this study
To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA alleles. Patients with "true" HLA 3/6 and 4/6 matches were evaluated. In addition, a separate study in adults addressed the problem of limited cell dose and engraftment failure. The study was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III efficacy study.
Read the detailed description
BACKGROUND:
Bone marrow transplantation is an effective therapy for a variety of genetic and hematologic disorders. Donated bone marrow, which provides a source of stem and progenitor cells for bone marrow reconstitution, is obtained either from related donors, usually HLA-matched siblings, or from HLA-matched unrelated donors. Because of the limited availability of HLA-matched related donors, HLA-matched unrelated donors are frequently the only alternative source of bone marrow for transplantation. To provide matched volunteer bone marrow donors for unrelated recipients, the National Marrow Donor Program (NMDP) was established in 1986 to develop a national Registry of HLA-typed individuals who agree to donate bone marrow if needed. More than 3 million potential marrow donors are now enrolled. A limitation of the registry approach is the time needed to identify a donor and complete the necessary clinical evaluation and laboratory testing for histocompatibility, infectious diseases, and general good health. Moreover, a certain proportion of potential donors change their minds or otherwise become unavailable between the time they enter the Registry and the time they are called as a preliminary match for a patient. Another disadvantage is the marrow harvesting procedure which requires the normal donor to be hospitalized and given general anesthesia in an operating room. Finally, the NMDP Registry consists of potential donors that are primarily of European Caucasian ancestry. Although great strides have been made in increasing the numbers of African-Americans, Hispanics, Asian-Americans, and Native Americans, it is still more difficult to find matches for these ethnic minorities than for Caucasian patients.
Human umbilical cord blood is an alternative source of hematopoietic stem and progenitor cells capable of reconstituting the bone marrow of recipients with a variety of diseases. Cord blood stem and progenitor cells from related donors have been successfully transplanted world-wide in children with genetic or hematologic diseases. These results suggested that cord blood from unrelated, HLA-matched donors also can be used for patients who need a transplant but don't have a related donor. The existing problems in unrelated-donor bone marrow transplantation with donor recruitment, bone marrow harvesting, and matching for antigens peculiar to a particular ethnic group would be reduced if typed, tested, and frozen umbilical cord blood could be made easily and rapidly available. Such a system, which could complement or partially replace the present process, has been shown to be feasible. In an NHLBI-sponsored program, investigators have collected and cryopreserved a bank of about 9,000 human UCBUs. In addition, successful searches and matches (including many 4/6 antigen matches) have resulted in more than 900 unrelated-donor, UCBU transplants to date. Preliminary data from both these unrelated-donor and other related-donor cord blood transplants suggest that there is less GvHD than if the source of the graft were adult bone marrow. The severity of GvHD also seems less even in highly mismatched recipients. One important question is whether or not 3/6 HLA matched transplants in children will have acceptable 180-day disease free survival. It also remains to be determined if the graft-vs-leukemia effect is also less or if unrelated-donor cord blood grafts are as durable as those from matched, related-donors. Most transplants conducted thus far have been in children. Hence another important question is whether or not there are sufficient numbers of stem cells in cord blood to support transplantation to an unrelated adult.
The initiative was proposed by the Division of Blood Diseases and Resources staff and approved by the February 1995 National Heart, Lung, and Blood Advisory Council. The Requests for Proposals were released in June 1995. Contracts were awarded September 30, 1997.
DESIGN NARRATIVE:
The study is multicenter, with six Cord Blood Transplant Centers (CBTCs), two collecting and storage centers (Cord Blood Banks -- CBBs) and one Coordinating Center. Each CBB used the same protocol for recruiting donors, collecting, processing, testing, storage, retrieval from storage, reprocessing from the frozen state, and shipping. Each participating CBTC used the same patient selection criteria, preparative regimen for patients in the same class, initial graft-versus-host disease (GvHD) prophylaxis, indications for the use of cytokines, definitions for events and complications, and methods for evaluating immune reconstitution. The main study evaluated the impact of HLA 3/6 and 4/6 matching on outcome. The primary endpoint was 180-day disease free survival after UCBU transplantation. Secondary endpoints included engraftment, the frequency and severity of acute and chronic GvHD with stratification by degree of HLA match, overall survival, and immunologic reconstitution. Data were collected on banked UCBUs to define unit quality by nucleated cell count and flow cytometry of surface markers to identify effects on patient outcome. Recruitment ended December 31, 2003 with the accrual of 326 subjects. .
- Conditions
- Anemia, Aplastic, Fanconi Anemia, Hematologic Diseases, Leukemia, Neoplasms, Severe Combined Immunodeficiency
- Being tested
- stem cell transplantation
- Medical subject headings
- Anemia, Aplastic, Fanconi Anemia, Hematologic Diseases, Leukemia, Neoplasms, Severe Combined Immunodeficiency, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1996
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Anemia, AplasticStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Shelly Carter, The Emmes Company, LLCJoanne Kurtzberg, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000603
- Sponsor's protocol ID
- 316
- Status last verified
- Jan 2008
- First submitted
- 27 Oct 1999
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
Wagner JE, Kurtzberg J. Banking and transplantation of unrelated donor umbilical cord blood: status of the National Heart, Lung, and Blood Institute-sponsored trial. Transfusion. 1998 Sep;38(9):807-9. doi: 10.1046/j.1537-2995.1998.38998408998.x. No abstract available.
PubMed 9738618Fraser JK, Cairo MS, Wagner EL, McCurdy PR, Baxter-Lowe LA, Carter SL, Kernan NA, Lill MC, Slone V, Wagner JE, Wallas CH, Kurtzberg J. Cord Blood Transplantation Study (COBLT): cord blood bank standard operating procedures. J Hematother. 1998 Dec;7(6):521-61. doi: 10.1089/scd.1.1998.7.521.
PubMed 9919946Laughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22. doi: 10.1056/NEJM200106143442402.
PubMed 11407342Barker JN, Wagner JE. Umbilical cord blood transplantation: current practice and future innovations. Crit Rev Oncol Hematol. 2003 Oct;48(1):35-43. doi: 10.1016/s1040-8428(03)00092-1.
PubMed 14585482Staba SL, Escolar ML, Poe M, Kim Y, Martin PL, Szabolcs P, Allison-Thacker J, Wood S, Wenger DA, Rubinstein P, Hopwood JJ, Krivit W, Kurtzberg J. Cord-blood transplants from unrelated donors in patients with Hurler's syndrome. N Engl J Med. 2004 May 6;350(19):1960-9. doi: 10.1056/NEJMoa032613.
PubMed 15128896Laughlin MJ, Eapen M, Rubinstein P, Wagner JE, Zhang MJ, Champlin RE, Stevens C, Barker JN, Gale RP, Lazarus HM, Marks DI, van Rood JJ, Scaradavou A, Horowitz MM. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004 Nov 25;351(22):2265-75. doi: 10.1056/NEJMoa041276.
PubMed 15564543Cornetta K, Laughlin M, Carter S, Wall D, Weinthal J, Delaney C, Wagner J, Sweetman R, McCarthy P, Chao N. Umbilical cord blood transplantation in adults: results of the prospective Cord Blood Transplantation (COBLT). Biol Blood Marrow Transplant. 2005 Feb;11(2):149-60. doi: 10.1016/j.bbmt.2004.11.020.
PubMed 15682076Wall DA, Carter SL, Kernan NA, Kapoor N, Kamani NR, Brochstein JA, Frangoul H, Goyal RK, Horan JT, Pietryga D, Wagner JE, Kurtzberg J; COBLT Steering Committee. Busulfan/melphalan/antithymocyte globulin followed by unrelated donor cord blood transplantation for treatment of infant leukemia and leukemia in young children: the Cord Blood Transplantation study (COBLT) experience. Biol Blood Marrow Transplant. 2005 Aug;11(8):637-46. doi: 10.1016/j.bbmt.2005.05.003.
PubMed 16041314Cairo MS, Wagner EL, Fraser J, Cohen G, van de Ven C, Carter SL, Kernan NA, Kurtzberg J. Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: a Cord Blood Transplantation (COBLT) Study report. Transfusion. 2005 Jun;45(6):856-66. doi: 10.1111/j.1537-2995.2005.04429.x.
PubMed 15934982Kurtzberg 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 15934981Kurtzberg J, Prasad VK, Carter SL, Wagner JE, Baxter-Lowe LA, Wall D, Kapoor N, Guinan EC, Feig SA, Wagner EL, Kernan NA; COBLT Steering Committee. Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies. Blood. 2008 Nov 15;112(10):4318-27. doi: 10.1182/blood-2007-06-098020. Epub 2008 Aug 21.
PubMed 18723429
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Blood Stem Cell Transplantation Study (COBLT)
- ClinicalTrials.gov ID
- NCT00000603
- Acronym / sponsor ID
- 316
- Conditions
- Anemia, Aplastic, Fanconi Anemia, Hematologic Diseases, Leukemia, Neoplasms, Severe Combined Immunodeficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1996
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Oct 1999 (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.
To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA alleles. Patients with "true" HLA 3/6 and 4/6 matches were evaluated. In addition, a separate study in adults addressed the problem of limited cell dose and engraftment failure. The study was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III efficacy study.
Detailed description
BACKGROUND:
Bone marrow transplantation is an effective therapy for a variety of genetic and hematologic disorders. Donated bone marrow, which provides a source of stem and progenitor cells for bone marrow reconstitution, is obtained either from related donors, usually HLA-matched siblings, or from HLA-matched unrelated donors. Because of the limited availability of HLA-matched related donors, HLA-matched unrelated donors are frequently the only alternative source of bone marrow for transplantation. To provide matched volunteer bone marrow donors for unrelated recipients, the National Marrow Donor Program (NMDP) was established in 1986 to develop a national Registry of HLA-typed individuals who agree to donate bone marrow if needed. More than 3 million potential marrow donors are now enrolled. A limitation of the registry approach is the time needed to identify a donor and complete the necessary clinical evaluation and laboratory testing for histocompatibility, infectious diseases, and general good health. Moreover, a certain proportion of potential donors change their minds or otherwise become unavailable between the time they enter the Registry and the time they are called as a preliminary match for a patient. Another disadvantage is the marrow harvesting procedure which requires the normal donor to be hospitalized and given general anesthesia in an operating room. Finally, the NMDP Registry consists of potential donors that are primarily of European Caucasian ancestry. Although great strides have been made in increasing the numbers of African-Americans, Hispanics, Asian-Americans, and Native Americans, it is still more difficult to find matches for these ethnic minorities than for Caucasian patients.
Human umbilical cord blood is an alternative source of hematopoietic stem and progenitor cells capable of reconstituting the bone marrow of recipients with a variety of diseases. Cord blood stem and progenitor cells from related donors have been successfully transplanted world-wide in children with genetic or hematologic diseases. These results suggested that cord blood from unrelated, HLA-matched donors also can be used for patients who need a transplant but don't have a related donor. The existing problems in unrelated-donor bone marrow transplantation with donor recruitment, bone marrow harvesting, and matching for antigens peculiar to a particular ethnic group would be reduced if typed, tested, and frozen umbilical cord blood could be made easily and rapidly available. Such a system, which could complement or partially replace the present process, has been shown to be feasible. In an NHLBI-sponsored program, investigators have collected and cryopreserved a bank of about 9,000 human UCBUs. In addition, successful searches and matches (including many 4/6 antigen matches) have resulted in more than 900 unrelated-donor, UCBU transplants to date. Preliminary data from both these unrelated-donor and other related-donor cord blood transplants suggest that there is less GvHD than if the source of the graft were adult bone marrow. The severity of GvHD also seems less even in highly mismatched recipients. One important question is whether or not 3/6 HLA matched transplants in children will have acceptable 180-day disease free survival. It also remains to be determined if the graft-vs-leukemia effect is also less or if unrelated-donor cord blood grafts are as durable as those from matched, related-donors. Most transplants conducted thus far have been in children. Hence another important question is whether or not there are sufficient numbers of stem cells in cord blood to support transplantation to an unrelated adult.
The initiative was proposed by the Division of Blood Diseases and Resources staff and approved by the February 1995 National Heart, Lung, and Blood Advisory Council. The Requests for Proposals were released in June 1995. Contracts were awarded September 30, 1997.
DESIGN NARRATIVE:
The study is multicenter, with six Cord Blood Transplant Centers (CBTCs), two collecting and storage centers (Cord Blood Banks -- CBBs) and one Coordinating Center. Each CBB used the same protocol for recruiting donors, collecting, processing, testing, storage, retrieval from storage, reprocessing from the frozen state, and shipping. Each participating CBTC used the same patient selection criteria, preparative regimen for patients in the same class, initial graft-versus-host disease (GvHD) prophylaxis, indications for the use of cytokines, definitions for events and complications, and methods for evaluating immune reconstitution. The main study evaluated the impact of HLA 3/6 and 4/6 matching on outcome. The primary endpoint was 180-day disease free survival after UCBU transplantation. Secondary endpoints included engraftment, the frequency and severity of acute and chronic GvHD with stratification by degree of HLA match, overall survival, and immunologic reconstitution. Data were collected on banked UCBUs to define unit quality by nucleated cell count and flow cytometry of surface markers to identify effects on patient outcome. Recruitment ended December 31, 2003 with the accrual of 326 subjects. .
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 14 Apr 2016.
- Background: PubMed 9738618Wagner JE, Kurtzberg J. Banking and transplantation of unrelated donor umbilical cord blood: status of the National Heart, Lung, and Blood Institute-sponsored trial. Transfusion. 1998 Sep;38(9):807-9. doi: 10.1046/j.1537-2995.1998.38998408998.x. No abstract available.
- Background: PubMed 9919946Fraser JK, Cairo MS, Wagner EL, McCurdy PR, Baxter-Lowe LA, Carter SL, Kernan NA, Lill MC, Slone V, Wagner JE, Wallas CH, Kurtzberg J. Cord Blood Transplantation Study (COBLT): cord blood bank standard operating procedures. J Hematother. 1998 Dec;7(6):521-61. doi: 10.1089/scd.1.1998.7.521.
- Background: PubMed 11407342Laughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22. doi: 10.1056/NEJM200106143442402.
- Background: PubMed 14585482Barker JN, Wagner JE. Umbilical cord blood transplantation: current practice and future innovations. Crit Rev Oncol Hematol. 2003 Oct;48(1):35-43. doi: 10.1016/s1040-8428(03)00092-1.
- Background: PubMed 15128896Staba SL, Escolar ML, Poe M, Kim Y, Martin PL, Szabolcs P, Allison-Thacker J, Wood S, Wenger DA, Rubinstein P, Hopwood JJ, Krivit W, Kurtzberg J. Cord-blood transplants from unrelated donors in patients with Hurler's syndrome. N Engl J Med. 2004 May 6;350(19):1960-9. doi: 10.1056/NEJMoa032613.
- Background: PubMed 15564543Laughlin MJ, Eapen M, Rubinstein P, Wagner JE, Zhang MJ, Champlin RE, Stevens C, Barker JN, Gale RP, Lazarus HM, Marks DI, van Rood JJ, Scaradavou A, Horowitz MM. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004 Nov 25;351(22):2265-75. doi: 10.1056/NEJMoa041276.
- Background: PubMed 15682076Cornetta K, Laughlin M, Carter S, Wall D, Weinthal J, Delaney C, Wagner J, Sweetman R, McCarthy P, Chao N. Umbilical cord blood transplantation in adults: results of the prospective Cord Blood Transplantation (COBLT). Biol Blood Marrow Transplant. 2005 Feb;11(2):149-60. doi: 10.1016/j.bbmt.2004.11.020.
- Background: PubMed 16041314Wall DA, Carter SL, Kernan NA, Kapoor N, Kamani NR, Brochstein JA, Frangoul H, Goyal RK, Horan JT, Pietryga D, Wagner JE, Kurtzberg J; COBLT Steering Committee. Busulfan/melphalan/antithymocyte globulin followed by unrelated donor cord blood transplantation for treatment of infant leukemia and leukemia in young children: the Cord Blood Transplantation study (COBLT) experience. Biol Blood Marrow Transplant. 2005 Aug;11(8):637-46. doi: 10.1016/j.bbmt.2005.05.003.
- Background: PubMed 15934982Cairo MS, Wagner EL, Fraser J, Cohen G, van de Ven C, Carter SL, Kernan NA, Kurtzberg J. Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: a Cord Blood Transplantation (COBLT) Study report. Transfusion. 2005 Jun;45(6):856-66. doi: 10.1111/j.1537-2995.2005.04429.x.
- 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.
- Derived from this study: PubMed 18723429Kurtzberg J, Prasad VK, Carter SL, Wagner JE, Baxter-Lowe LA, Wall D, Kapoor N, Guinan EC, Feig SA, Wagner EL, Kernan NA; COBLT Steering Committee. Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies. Blood. 2008 Nov 15;112(10):4318-27. doi: 10.1182/blood-2007-06-098020. Epub 2008 Aug 21.
Related trials for Anemia, Aplastic
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Aplastic Anemia
RecruitingObservational study
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
Severe Aplastic Anemia, Telomere Biology Disorders
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
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.
Shelly Carter
The Emmes Company, LLC
Joanne Kurtzberg
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stem cell transplantation in people with Anemia, Aplastic and Fanconi Anemia, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000603, which also lists 11 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 14 Apr 2016.