Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

NCT05456243 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 21-012522
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• Worsening kidney allograft rejection

  Number of subjects to have biopsy-proven worsening kidney allograft rejection

  28 days after A-MSC infusion

• Adverse Events

  Number of Grade 3 or higher AEs attributable to the A-MSC infusion including infusion reaction/cytokine release syndrome, per the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). Cytokine Release Syndrome (CRS) will be defined using the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cell

  1 year

Study Arms (2)

Low Dose Group

EXPERIMENTAL

Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one low dose of allogeneic A-MSC.

Biological: Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)

High Dose Group

EXPERIMENTAL

Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one high dose of allogeneic A-MSC.

Biological: High dose adipose tissue derived mesenchymal stromal cells (A-MSC)

Interventions

Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) BIOLOGICAL

Single intra-arterial infusion of 1 x 10\^5 cells/kg

Low Dose Group

High dose adipose tissue derived mesenchymal stromal cells (A-MSC) BIOLOGICAL

Single intra-arterial infusion of 5 x 10\^5 cells/kg infused over 5 minutes

High Dose Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Stable renal function:
• Serum creatinine at the time of surveillance biopsy cannot be \> 15% greater than the serum creatine prior to the biopsy (must be within 3 months of the biopsy);
• Estimated eGFR \> 30 ml/min by MDRD.
• Histologic Criteria for Eligibility:
• ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular capillaritis (ptc) (g:1 or 2; ptc:1 or 2).
• Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2); intimal arteritis (v) (v: 1 or 2).
• Mixed ABMR and cellular rejection.

You may not qualify if:

• 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:
• o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT) ≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0, Platelet count \< 50 x 109/L (patients who receive a platelet transfusion to increase their platelet count will not be excluded).
• One or more of the following parameters:
• o Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤ 90%, Systemic systolic blood pressure \>160mmHg or \< 100 mmHg, Pulse \< 45/min or \> 140/min
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Timucin Taner, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: January 30, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)