CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

November 29, 2021 updated by: Samuel Vilchez

Chronic Kidney Disease of Unknown Cause (CKDu) Treated With Directed Local Intra-arterial Infusion of Autologous Stromal Vascular Fraction (SVF) Cells.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).

Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.

Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nicaragua
      • Leon, Nicaragua
        • Hospital Escuela Oscar Danilo Rosales Arguello

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.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral Treatment
Intra-arterial injection of SVF cells into the kidneys.
Genetic: Adipose-derived stromal vascular fraction cells
Kidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment related adverse events
Time Frame: 36-months follow-up post intervention.
Documentation of adverse events
36-months follow-up post intervention.
Preliminary evidence of efficacy
Time Frame: Assessment of changes between day 7 and month 36 post intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal blood flow.
Time Frame: Up to month 12 post intervention.
Distribution of intra-renal blood flow.
Up to month 12 post intervention.
Kidney volume.
Time Frame: Up to month 12 post intervention.
Changes in kidney size (cm3).
Up to month 12 post intervention.
Renal arterial resistive index.
Time Frame: Up to month 12 post intervention.
Decreases in hilar artery resistance index (less o equal to 0.7).
Up to month 12 post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Vilchez

Collaborators

National Autonomous University of Nicaragua
Ministerio de Salud de Nicaragua
GID BIO

Investigators

  • Principal Investigator: Michael Carstens, MD, Wake Forrest Institute for Regenerative Medicine
  • Principal Investigator: Diego Correa, MD, PhD, University of Miami
  • Study Director: Sreedhar Mandayam, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

November 6, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVF2015MeN-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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