NCT05154591

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

November 6, 2021

Last Update Submit

November 8, 2023

Conditions

Chronic Renal Failure of Unknown Cause

Keywords

Stromal vascular fractionMesenchynmal stem cellsChronic kidney diseaseAdipose stem cells

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment related adverse events

    Documentation of adverse events

    36-months follow-up post intervention.

  • Preliminary evidence of efficacy

    Improvement in clinical parameter of GFR as compared with historical age and stage-matched controls.

    Assessment of changes between day 7 and month 36 post intervention.

Secondary Outcomes (3)

  • Renal blood flow.

    Up to month 12 post intervention.

  • Kidney volume.

    Up to month 12 post intervention.

  • Renal arterial resistive index.

    Up to month 12 post intervention.

Study Arms (1)

Bilateral Treatment

EXPERIMENTAL

Intra-arterial injection of SVF cells into the kidneys.

Genetic: Adipose-derived stromal vascular fraction cells

Interventions

Adipose-derived stromal vascular fraction cellsGENETIC

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

Bilateral Treatment

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Mesoamerican nephropathy
  • Stages 3 and 4
  • No other renal disease
  • No essential hypertension

You may not qualify if:

  • Significant abnormalities in laboratory tests that contraindicate surgical procedures.
  • Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:
  • Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb \<9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Escuela Oscar Danilo Rosales Arguello

León, Nicaragua

Location

Related Publications (8)

  • Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.

    PMID: 28177263RESULT

  • Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.

    PMID: 21726829RESULT

  • Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Rios AB, Rivera CM, Calero DW, Zelaya ML, Garcia N, Bertram KA, Rigdon J, Dos-Anjos S, Correa D. Treatment of chronic diabetic foot ulcers with adipose-derived stromal vascular fraction cell injections: Safety and evidence of efficacy at 1 year. Stem Cells Transl Med. 2021 Aug;10(8):1138-1147. doi: 10.1002/sctm.20-0497. Epub 2021 Apr 7.

    PMID: 33826245RESULT

  • Correa-Rotter R, Garcia-Trabanino R. Mesoamerican Nephropathy. Semin Nephrol. 2019 May;39(3):263-271. doi: 10.1016/j.semnephrol.2019.02.004.

    PMID: 31054625RESULT

  • Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.

    PMID: 26546112RESULT

  • Johnson RJ, Wesseling C, Newman LS. Chronic Kidney Disease of Unknown Cause in Agricultural Communities. N Engl J Med. 2019 May 9;380(19):1843-1852. doi: 10.1056/NEJMra1813869. No abstract available.

    PMID: 31067373RESULT

  • Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.

    PMID: 26565755RESULT

  • Wijkstrom J, Gonzalez-Quiroz M, Hernandez M, Trujillo Z, Hultenby K, Ring A, Soderberg M, Aragon A, Elinder CG, Wernerson A. Renal Morphology, Clinical Findings, and Progression Rate in Mesoamerican Nephropathy. Am J Kidney Dis. 2017 May;69(5):626-636. doi: 10.1053/j.ajkd.2016.10.036. Epub 2017 Jan 23.

    PMID: 28126239RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Carstens, MD

    Wake Forrest Institute for Regenerative Medicine

    PRINCIPAL INVESTIGATOR

  • Diego Correa, MD, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Sreedhar Mandayam, MD

    University of Texas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
* Open label for surgeons and radiologists * Closed label for pathologists and nephrologists
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 13, 2021

Study Start

January 1, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

NI(1)