ACTIVE_NOT_RECRUITING

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

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Conditions

Kidney TransplantRenal Transplant Recipientsdonor recipient pairsallogeneic regulatory dendritic cell therapy (DCreg)DCreg therapyde novo (first) live-donor renal transplant recipients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients. DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. This study will enroll 28 subjects (14 recipients, 14 donors). The duration of follow-up will be: * 1 week following the leukapheresis procedure for donors and * 2 years following their DCreg infusion for kidney recipients.

Official Title

Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients

Quick Facts

Study Start:2019-04-10
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03726307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to understand and provide informed consent;
  2. * Male or female \>/= 18 years of age
  3. * Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
  4. * For females of childbearing potential, a negative urine or serum pregnancy test;
  5. * Negative for Human Immunodeficiency Virus type 1 (HIV) -1 (antigen and Nucleic Acid Testing (NAT)), HIV-2, Human T-cell leukemia virus type 1 (HTLV-1), and HTLV-2;
  6. * Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection;
  7. * Negative for West Nile Virus;
  8. * Negative health history for Creutzfeldt-Jakob disease;
  9. * No live vaccines within 8 weeks prior to leukapheresis;
  10. * No medical condition(s) that the investigator deems incompatible with participation in the trial; and
  11. * No use of investigational drugs within 12 weeks of participation.
  1. * Panel Reactive Antibody (PRA \>20%);
  2. * Positive T or B Cell Flow Crossmatch prior to transplant;
  3. * Presence of donor specific antibody (DSA) ≥ to mean fluorescence intensity (MFI) of 1000, or DSA between 500 and 1000, if a specific shared epitope pattern is present;
  4. * Recipient of multi-organ transplant;
  5. * Any prior renal or extra-renal transplant with HLA class II antigen mismatch shared with prior organ;
  6. * Epstein-Barr Virus (EBV) Immunoglobulin G (IgG) negative if the donor is EBV positive;
  7. * Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (HCV) antibody (if hepatitis C antibody positive, confirm negative infection by HCV RNA), or positivity for hepatitis B surface antigen;
  8. * History of malignancy witin the past 5 years unless standard institutional criteria detailed in Appendix 6 have been met;
  9. * High risk for recurrence of renal disease: Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura (HUS-TTP); Focal Segmental Glomerular Sclerosis (FSGS); or Aggressive native kidney disease.
  10. * Compensated and decompensated cirrhosis of liver and/or portal hypertension;
  11. * Chronic Obstructive Pulmonary Disease requiring nasal oxygen, and/or pulmonary hypertension (mean pulmonary pressure \>45mm/hg);
  12. * Any history of stroke with neurological deficit;
  13. * Any condition that, in the opinion of the investigator, confers excessive risk for participation in this phase 1 study;
  14. * Presence of a condition that requires treatment with an immunosuppressive agent, other than a physiologic dose of corticosteroid;
  15. * Live vaccines within 8 weeks prior to transplant;
  16. * Use of investigational drugs within 12 weeks of participation;
  17. * Woman receiving a kidney from a man who has fathered her child(ren), whether or not carried to term; or
  18. * Woman receiving a kidney from her biological child.

Contacts and Locations

Principal Investigator

Amit D. Tevar, MD, FACS
STUDY_CHAIR
University of Pittsburgh: Starzl Transplantation Institute

Study Locations (Sites)

University of Pittsburgh, Starzl Transplantation Institute
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Angus W. Thomson PhD DSc

  • Amit D. Tevar, MD, FACS, STUDY_CHAIR, University of Pittsburgh: Starzl Transplantation Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-10
Study Completion Date2027-03

Study Record Updates

Study Start Date2019-04-10
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • donor recipient pairs
  • allogeneic regulatory dendritic cell therapy (DCreg)
  • DCreg therapy
  • de novo (first) live-donor renal transplant recipients

Additional Relevant MeSH Terms

  • Kidney Transplant
  • Renal Transplant Recipients