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Cell Therapy

Treg Cells + Everolimus for Kidney Transplant Rejection

N/A

Waitlist Available

Led By Roberto Gedaly, MD

Research Sponsored by Roberto Gedaly

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

End stage renal disease listed for primary solitary kidney transplant

Female participants must agree to use 2 different birth control methods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 12 weeks post transplant

Awards & highlights

Study Summary

This trial is investigating the use of Treg cells to prevent kidney rejection in patients undergoing a solitary kidney transplant. 12 participants will be enrolled at the University of Kentucky.

Who is the study for?

This trial is for English-speaking adults with end-stage renal disease who are set to receive their first kidney transplant. They must be willing to follow the study rules and women need to use two forms of birth control. It's not open to those with previous transplants, certain drug sensitivities, chronic steroid or immunosuppressant use, significant infections like HIV or hepatitis, recent cancer history, other recent clinical trials participation, poor wound healing, refusal of birth control methods or non-compliance.Check my eligibility

What is being tested?

The study tests if using a patient's own Regulatory T cells (Treg cells), expanded in a lab and infused back into them can help prevent kidney rejection when taking Zortress (Everolimus) after a kidney transplant. The process involves collecting Treg cells through apheresis—a procedure where blood is drawn and processed to extract these specific cells.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion of Treg cells such as fever or chills and risks associated with Everolimus which can include mouth ulcers, increased cholesterol levels, lower blood cell counts increasing infection risk, impaired wound healing and possible impact on fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on the list for a kidney transplant due to end stage kidney disease.

Select...

I agree to use two different forms of birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6 and 12 months post tregs infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 6 and 12 months post tregs infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6 and 12 months post tregs infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes In Steroid Resistance Rejection Rates

Changes in Kidney Function

Changes in Tregs Infusion Toxicities

+1 more

Secondary outcome measures

Circulating T cell subset measurements

Treg cell measurements within the allograft

Side effects data

From 2010 Phase 2 trial • 170 Patients • NCT00001832

100%

Leukocyte count decreased

100%

Lymphocyte count decreased

100%

Neutrophil count decreased

33%

Bilirubin increased

33%

Hemoglobin decreased

33%

Serum albumin decreased

100%

80%

60%

40%

20%

Study treatment Arm

Abl Cells IV + Cyclophosphamide 30 mg/kg

Abl Cells IV + Cyclophosphamide 60 mg/kg

Abl Cells IV+Low Dose IV IL-2 (Initial)

Abl Cells IV+High Dose IV IL-2 (Initial)

Abl Cells IV + MTD IL-2

Abl Cells IA + MTD (Prior Cells IV on 6)

Abl Cells IA + MTD IL-2

Abl Cells IA+MTD IL-2 (MART-1 Reactive)

Abl Cells IV + MTD IL-2 no GCSF

Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)

Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)

Abl Cells IV + SQ IL-2 With GCSF

Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)

Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous Treg InfusionExperimental Treatment1 Intervention

This will be a single intravenous (IV) infusion. A participant's own expanded regulatory T cells will be added to Albumin, and administered to them. The amount of the solution will be approximately 300 ml and the infusion will take about 3 to 4 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apheresis

2003

Completed Phase 2

~660

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roberto GedalyLead Sponsor

1 Previous Clinical Trials

78 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,341 Total Patients Enrolled

Roberto Gedaly, MDPrincipal Investigator - University of Kentucky

University of Kentucky Albert B. Chandler Hospital

University Central De Venezuela (Medical School)

2 Previous Clinical Trials

78 Total Patients Enrolled

Media Library

Autologous Regulatory T Cell Infusion (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03284242 — N/A

Kidney Transplant Research Study Groups: Autologous Treg Infusion

Kidney Transplant Clinical Trial 2023: Autologous Regulatory T Cell Infusion Highlights & Side Effects. Trial Name: NCT03284242 — N/A

Autologous Regulatory T Cell Infusion (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03284242 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research endeavor?

"To qualify for this research initiative, prospective participants must have kidney failure, be of chronic nature and fall within the age range of 18-65. Approximately 12 recruits are needed to participate in this study."

Answered by AI

Does this clinical trial include participants under the age of 40?

"This trial can accommodate participants aged 18 to 65. There are 23 independent studies for those younger and 246 trials specifically tailored to the elderly population."

Answered by AI

How many participants are taking part in this experiment?

"Affirmative. The information available on clinicaltrials.gov attests that this medical trial, initially published on March 15th 2019, is actively recruiting patients. A single site is admitting 12 people for the study."

Answered by AI

Are there any opportunities currently available to enroll in this research?

"Affirmative. The relevant data found on clinicaltrials.gov confirms that this medical study, which was first listed on March 15th 2019, is actively seeking subjects to enrol in the trial. A mere 12 patients are required from 1 site for participation and the last update occurred on May 16th 2022."

Answered by AI

Recent research and studies

TransplantationJournal

Mtor Inhibitor Everolimus in Regulatory T Cell Expansion for Clinical Application in Transplantation

Gedaly, Roberto, Felice De Stefano, Lilia Turcios, Marita Hill, Giovanna Hidalgo, Mihail I. Mitov, Michael C. Alstott, et al.. 2019. “Mtor Inhibitor Everolimus in Regulatory T Cell Expansion for Clinical Application in Transplantation”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0000000000002495.

clinicaltrials.govStudy

A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients

Roberto Gedaly 2019. "A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03284242.