Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date March 2022
Source Enzyvant Therapeutics GmBH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Thymic engraftment will be determined by biopsy of the thymus allograft and immunohistochemical evidence of thymopoiesis. In addition, we would like 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. These data will be compared to age, stem-cell donor source and disease matched historical controls whose stem cell transplants were not followed by a thymus transplant. This will be done in descriptive fashion. Other immune parameters will be followed including T, B, and NK cell numbers, T cell responses to mitogens, antigens, and immunoglobulin production.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Thymic Transplantation for Recipients of UCB transplant
Subjects with hematologic malignancies or bone marrow failure disorders will undergo umbilical cord blood transplantation and two months post transplant will have thymic tissue from a third party donor transplanted into the thigh muscle.

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Enzyvant Therapeutics GmBH

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  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