RECRUITING

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Conditions

Quick Navigation

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 research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the transplanted kidney and treat rejection.

Official Title

Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)

Quick Facts

Study Start:2023-01-30

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05456243

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 to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Able to understand and provide informed consent. * Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.	* Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening. * History of post-transplant intervention for obstructive uropathy * One or more of the following laboratory values: * One or more of the following parameters: * Patients with the following grades/classes of vascular diseases: * NYHA Class 3-4 CHF * Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular response, supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled chronic atrial fibrillation will be allowed to participate. * Cerebrovascular accident (CVA) within 90 days of screening * Peripheral Arterial Disease (PAD), patients who have had prior vascular interventions for PAD in the index lower extremity. * Acute illness within 30 days of screening. * History of allergy or intolerance to iodinated contrast agents * Women of childbearing potential or male subjects with female partners of childbearing potential unwilling to use an effective method of contraception during and for 12 months post-treatment. * History of or current evidence of alcohol abuse, illicit drug use or dependence * Active COVID 19 or positive test for the SARS-CoV-2 virus * History of malignancy within 5 years of enrollment. History of adequately treated in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous cell) will be permitted * Serologic evidence of human immunodeficiency virus 1 or 2 infection * Epstein Barr Virus (EBV) sero-negativity (EBV naïve) * Cytomegalovirus (CMV) sero-negativity * Active post-transplant opportunistic infections at the time of screening (CMV, BK virus, polyoma virus, EBV) * Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV IgG positive), or those with HBV surface antibody positive but HBV core antibody negative subjects will not be excluded from the study. * Have received a kidney transplant from a Hepatitis C positive donor and plan to receive anti-viral treatment after transplant * Any chronic condition for which anti-coagulation cannot be safely interrupted for kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall into either the high or the moderate thrombotic risk, they will be deemed to be not safe to interrupt anticoagulation: * High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months) stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6, CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within 3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or antithrombin; antiphospholipid antibodies; multiple abnormalities) * Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve prosthesis and 1 or more of the of following risk factors: atrial fibrillation, prior stroke or transient ischemic attack, hypertension, diabetes, congestive heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6; Venous thromboembolism: VTE within the past 3 to 12 months, non-severe thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation), recurrent VTE * For all other subjects, anticoagulation can be safely interrupted for 3 days prior to infusion and resumed a day after the infusion. * Positive pregnancy test * Participation in any other studies that involved investigational drugs or regimens in the preceding year * Any other condition, in the investigator's judgment, that increases the risk of A-MSC infusion or prevents safe trial participation * Unwilling or unable to adhere to study requirements and procedures * Per Banff criteria category 6: the presence of other changes not considered to be caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury, Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or Drug-Induced Interstitial Nephritis

Inclusion Criteria

Exclusion Criteria

* Able to understand and provide informed consent.
* Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.

* Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening.
* History of post-transplant intervention for obstructive uropathy
* One or more of the following laboratory values:
* One or more of the following parameters:
* Patients with the following grades/classes of vascular diseases:
* NYHA Class 3-4 CHF
* Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular response, supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled chronic atrial fibrillation will be allowed to participate.
* Cerebrovascular accident (CVA) within 90 days of screening
* Peripheral Arterial Disease (PAD), patients who have had prior vascular interventions for PAD in the index lower extremity.
* Acute illness within 30 days of screening.
* History of allergy or intolerance to iodinated contrast agents
* Women of childbearing potential or male subjects with female partners of childbearing potential unwilling to use an effective method of contraception during and for 12 months post-treatment.
* History of or current evidence of alcohol abuse, illicit drug use or dependence
* Active COVID 19 or positive test for the SARS-CoV-2 virus
* History of malignancy within 5 years of enrollment. History of adequately treated in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous cell) will be permitted
* Serologic evidence of human immunodeficiency virus 1 or 2 infection
* Epstein Barr Virus (EBV) sero-negativity (EBV naïve)
* Cytomegalovirus (CMV) sero-negativity
* Active post-transplant opportunistic infections at the time of screening (CMV, BK virus, polyoma virus, EBV)
* Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV IgG positive), or those with HBV surface antibody positive but HBV core antibody negative subjects will not be excluded from the study.
* Have received a kidney transplant from a Hepatitis C positive donor and plan to receive anti-viral treatment after transplant
* Any chronic condition for which anti-coagulation cannot be safely interrupted for kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall into either the high or the moderate thrombotic risk, they will be deemed to be not safe to interrupt anticoagulation:
* High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months) stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6, CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within 3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or antithrombin; antiphospholipid antibodies; multiple abnormalities)
* Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve prosthesis and 1 or more of the of following risk factors: atrial fibrillation, prior stroke or transient ischemic attack, hypertension, diabetes, congestive heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6; Venous thromboembolism: VTE within the past 3 to 12 months, non-severe thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation), recurrent VTE
* For all other subjects, anticoagulation can be safely interrupted for 3 days prior to infusion and resumed a day after the infusion.
* Positive pregnancy test
* Participation in any other studies that involved investigational drugs or regimens in the preceding year
* Any other condition, in the investigator's judgment, that increases the risk of A-MSC infusion or prevents safe trial participation
* Unwilling or unable to adhere to study requirements and procedures
* Per Banff criteria category 6: the presence of other changes not considered to be caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury, Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or Drug-Induced Interstitial Nephritis

Contacts and Locations

Principal Investigator

Timucin Taner, MD, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Timucin Taner, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2023-01-30

Study Completion Date2025-08

Study Record Updates

Study Start Date2023-01-30

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Kidney Transplant