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CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

NCT05154591 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-11-13

No results posted yet for this study

Summary

This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.

This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.

Conditions

  • Chronic Renal Failure of Unknown Cause

Interventions

GENETIC

Adipose-derived stromal vascular fraction cells

Kidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells.

Sponsors & Collaborators

  • Ministerio de Salud de Nicaragua

    collaborator UNKNOWN

  • GID BIO

    collaborator UNKNOWN

  • National Autonomous University of Nicaragua

    collaborator OTHER

  • Samuel Vilchez, PhD

    lead OTHER

Principal Investigators

  • Michael Carstens, MD · Wake Forrest Institute for Regenerative Medicine

  • Diego Correa, MD, PhD · University of Miami

  • Sreedhar Mandayam, MD · University of Texas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Nicaragua

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154591 on ClinicalTrials.gov