CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells

Sponsor

Samuel Vilchez (Other)

Overall Status

Completed

CT.gov ID

NCT05154591

Collaborator

Ministerio de Salud de Nicaragua (Other), GID BIO (Other), National Autonomous University of Nicaragua (Other)

Enrollment

Location

Arm

37.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Failure of Unknown Cause	Genetic: Adipose-derived stromal vascular fraction cells	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Open label for surgeons and radiologists Closed label for pathologists and nephrologists

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of treatment related adverse events [36-months follow-up post intervention.]
Documentation of adverse events
Preliminary evidence of efficacy [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Escuela Oscar Danilo Rosales Arguello	Leon		Nicaragua

Sponsors and Collaborators

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

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