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Cell Therapy
DCreg Cell Therapy for Kidney Transplant Recipients
Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Donor Eligibility Criteria: Able to understand and provide informed consent; Meets all standard institutional criteria for kidney donation and Health Agency compliance with kidney donation regulations; For females of childbearing potential, a negative urine or serum pregnancy test; Negative for tuberculosis by either a negative Purified Protein Derivative (PPD) test or Result using an approved interferon-gamma release assay (IGRA) blood test, such as QuantiFERON®-Gold TB or T-SPOT.TB assay, unless the participant has completed treatment for latent tuberculosis, and has a negative chest x-ray; 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; Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection; Negative for West Nile Virus; Negative health history for risk factors related to Zika Virus and Creutzfeldt-Jakob disease; No live vaccines within 8 weeks prior to leukapheresis; No medical condition(s) that the investigator deems incompatible with participation in the trial; No use of investigational drugs within 12 weeks of participation.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (seven days prior to transplant surgery, "pre" -regulatory dendritic cells (dcreg)) infusion) up to within 48 hours of transplant
Awards & highlights
Study Summary
This trial will study the safety and feasibility of using a single infusion of donor-derived regulatory dendritic cells (DCreg) in people who are getting a kidney transplant from a living donor.
Who is the study for?
This trial is for first-time kidney transplant recipients from living donors. Participants must understand and consent to the study, have no history of transplants or aggressive kidney disease, be negative for HIV, hepatitis B/C, tuberculosis (or treated if previously positive), and agree to use effective contraception if applicable. Donors must meet standard criteria for kidney donation.Check my eligibility
What is being tested?
The study tests a single infusion of donor-derived regulatory dendritic cells (DCreg) given to recipients 7 days before their kidney transplant. The goal is to assess safety and feasibility over two years with three different doses of DCreg plus standard care.See study design
What are the potential side effects?
As this is an early phase trial primarily assessing safety and feasibility, specific side effects are not detailed but may include typical risks associated with infusions such as immune reactions or infection risk increase.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (seven days prior to transplant surgery, "pre" -regulatory dendritic cells (dcreg)) infusion) up to within 48 hours of transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (seven days prior to transplant surgery, "pre" -regulatory dendritic cells (dcreg)) infusion) up to within 48 hours of transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Outcome: Proportion of Participants who Experience any of the Pre-Specified Safety Events
Secondary outcome measures
Incidence of Adverse Event: CTCAE Grade 4 or Higher Infusion Reaction
Incidence of Adverse Event: Malignancy
Incidence of Adverse Event:CTCAE Grade 4 or Higher Infection
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: DCreg:2.5 to 5.0 million cells/kg+SOCExperimental Treatment1 Intervention
N=8 participants will receive 25 to 5.0 million cells /kg body weight as a single infusion.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
Group II: DCreg: 1.2 million cells/kg+SOCExperimental Treatment1 Intervention
N=3 participants will receive 1.2 (± 0.2) million cells/kg body weight as a single infusion.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
Group III: DCreg: 0.5 million cells/kg+SOCExperimental Treatment1 Intervention
N=3 participants will receive 0.5 (± 0.1) million cells/kg body weight as a single infusion.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of PittsburghOTHER
1,723 Previous Clinical Trials
16,342,928 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,209 Total Patients Enrolled
Amit D. Tevar, MD, FACSStudy ChairUniversity of Pittsburgh: Starzl Transplantation Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: DCreg: 0.5 million cells/kg+SOC
- Group 2: DCreg: 1.2 million cells/kg+SOC
- Group 3: DCreg:2.5 to 5.0 million cells/kg+SOC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved DCreg:2.5 to 5.0 million cells/kg+SOC for use?
"The safety of DCreg:2.5 to 5.0 million cells/kg+SOC is rated a 1, as this Phase 1 trial has only limited data demonstrating its effectiveness and risk profile."
Answered by AI
Does the eligibility criterion for this trial prohibit those over 54 years of age?
"Per the inclusion guidelines, participants between 18 and 70 years old are eligible for this medical trial. For those under eighteen or above 65, there are 10 trials and 87 trials respectively that could offer alternate treatments."
Answered by AI
What criteria must potential participants meet in order to qualify for the clinical trial?
"This medical trial is recruiting 28 participants of kidney transplant age (18-70). Eligible individuals must be willing and able to provide informed consent, conform with the requisite institutional criteria for organ donation as well as governmental regulations, have a negative urine or serum pregnancy test if female, display no signs of tuberculosis via PPD testing/IGRA such as QuantiFERON®-Gold TB or T-SPOT.TB assay within 52 weeks before surgery (unless they are already treated), present negative results in tests for HIV type 1 & 2, HTLV1 &2 , Hepatitis b & C, Treponema pallid"
Answered by AI
Is this initiative currently recruiting participants?
"Affirmative. According to data posted on clinicaltrials.gov, this medical trial is actively searching for patients and was initially published on April 10th 2019. 28 participants need to be enrolled at 1 centre with the most recent update being made 4/30/2021."
Answered by AI
What is the capacity of this trial in terms of patient recruitment?
"Affirmative. According to records on clinicaltrials.gov, this exploration of medical treatments is presently seeking participants for inclusion. It was initially posted in April 2019 and the last update came at the end of April 2021 with 28 people needed from a single site."
Answered by AI
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