Stem Cell Transplantation Clinical Trial
Official title:
Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation
NCT number | NCT00597441 |
Other study ID # | Pro00007995 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | November 2005 |
Est. completion date | May 2010 |
Verified date | March 2022 |
Source | Enzyvant Therapeutics GmBH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation.
Status | Terminated |
Enrollment | 6 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Subjects who received a dual cord blood transplant are eligible and must have achieved donor cord blood chimerism of > 75% in both T-cell and myeloid lineages - At the time of thymus transplantation, subjects cannot have active grade II-IV acute graft versus host disease. - At the time of thymus transplantation, the subject must have an absolute neutrophil count of > 500/ul and a platelet count of 50,000/ul (even if achieved via transfusion). - At the time of thymus transplantation, the subject must have < or equal to 50 circulating CD 34+ cells/ul (as measured within 3 weeks of transplant date). - At the time of thymus transplantation, subjects cannot be on greater than 2 mg/kg/day methylprednisolone or its equivalent of steroids. - At the time of thymus transplantation, PT and PTT must be less that 1.5 times the ULN or must be correctable to this level. - At the time of thymus transplantation, subjects cannot require oxygen or have pulmonary disease that would be thought to make general anesthesia a high risk. - Subjects must be between the ages of 18 and 60 years of age. Exclusion Criteria: - Subjects cannot have bone marrow flow cytometry demonstrating residual leukemia - Subjects cannot have insufficient subcutaneous tissue and muscle mass to be able to accept and heal a thymus transplant, as assessed by a surgeon. - Prior to thymus transplantation, subjects cannot have evidence of active disease with HHV6, West Nile Virus, EBV, and CMV. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Enzyvant Therapeutics GmBH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. | 5 years | ||
Secondary | To determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated UCBT. Thymic engraftment will be determined by biopsy of the thymus allograft and immunohistochemical evidence of thymopoiesis. | 5 years | ||
Secondary | To assess thymic function by measuring the number of naive T cells and the number of T cell receptor rearrangement excision circles (TRECS), and by assessing the diversity of the T cell receptor beta chain. | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03918343 -
Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
|
N/A | |
Not yet recruiting |
NCT05438823 -
Technology Supported Education Program Based on Human Care Theory
|
N/A | |
Not yet recruiting |
NCT02193399 -
Physiotherapy in Hematopoietic Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT00972101 -
Infusion of Expanded Cord Blood T Cells
|
Phase 1 | |
Completed |
NCT05421299 -
A Study to Assess 7/8 HLA-matched Hematopoietic Stem Cell Transplantation Participants Treated With or Without Abatacept in Combination With a Calcineurin Inhibitor and Methotrexate
|
||
Completed |
NCT04976933 -
Post-HSCT Medication Adherence mHealth App
|
||
Completed |
NCT04798495 -
Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation
|
N/A | |
Completed |
NCT00612274 -
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation
|
Phase 0 | |
Active, not recruiting |
NCT04511130 -
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT05968963 -
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
|
N/A | |
Recruiting |
NCT02940093 -
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers
|
N/A | |
Not yet recruiting |
NCT06077734 -
Muscle Stem Cell Quality in Atrophy
|
||
Terminated |
NCT00587990 -
Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03684083 -
Inflammatory Response to Paramyxovirus Infection in an Ex-vivo Model of Bronchial Epithelial Cells in Allogeneic HSCT Recipients
|
||
Recruiting |
NCT00884338 -
Cognitive Function After Stem Cell Transplantation
|
Phase 3 | |
Completed |
NCT00284713 -
Progenitor Cell Therapy in Dilative Cardiomyopathy
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00062543 -
Hepatic Artery Infusion of CD34+ Cells
|
Phase 1 | |
Completed |
NCT00781170 -
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT03364257 -
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
|
||
Enrolling by invitation |
NCT06134297 -
Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
|
N/A |