NCT02693366

Brief Summary

The purpose of this study is to analyze the safety, renal function, metabolic disorders and quality of life data in patients with focal segmental glomerulosclerosis treated with endovascular infusion of bone marrow derived mononuclear cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

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

June 25, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

January 30, 2016

Last Update Submit

January 26, 2020

Conditions

Focal Segmental GlomerulosclerosisChronic Kidney Diseases

Keywords

bone marrow cellsFocal Segmental GlomerulosclerosisChronic Kidney Diseasesstem cellcell therapy

Outcome Measures

Primary Outcomes (5)

  • Kidney injury

    Increase of serum creatinine of about 0.5 mg / dL when levels are less than 3.0 mg / dl and 1.0 mg / dl baseline levels when are greater than or equal to 3.0 mg / dL) when confirmed with the second examination. * Acute: evaluated within 15 days of cell therapy; * Subacute: evaluated 15-90 days of cell therapy

    9 months

  • Chronic kidney disease

    Doubling of serum creatinine based on the third month after the cell therapy or the need to start dialysis

    9 months

  • Potential differentiation disorders of transplanted cells

    Analyzed by clinical and imaging tests such abdominal ultrasound and chest radiography

    9 months

  • Systemic inflammatory potential of mononuclear cells administration in renal circulation

    Laboratory tests: C-reactive protein, erythrocyte sedimentation rate, blood count and urinary sediment

    9 months

  • Death

    9 months

Secondary Outcomes (6)

  • Renal function

    9 months

  • Bone metabolism

    9 months

  • Balance assessment electrolyte and acid-base

    9 months

  • The lipid profile assessment and anemia

    9 months

  • Quality of life questionnaire

    9 months

  • +1 more secondary outcomes

Study Arms (1)

Autologous Cell Therapy

EXPERIMENTAL

We are conducting a prospective, non-randomized, single-center longitudinal study in five patients with progressive chronic kidney disease and estimated clearance between 40 and 20 ml / min. Patients will be followed by clinical and laboratory examination for 3 months prior to the procedure. These previous results serve as a control for comparison with a second time when the same patients receive treatment with stem cells being subsequently followed up for 9 months a total of one year of clinical follow-up.

Other: Bone marrow stem cell

Interventions

Bone marrow stem cellOTHER

Endovascular infusion of bone marrow derived cells in both renal arteries.

Autologous Cell Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with diagnosis of primary focal segmental glomerulosclerosis after having been previously treated with corticosteroids and immunosuppressive drugs and have not reached satisfactory answer. Will also be considered candidates those patients who performed late diagnosis and therefore no more clinical indication to perform therapy with corticosteroids and immunosuppressants. In both cases, showing irreversible loss of renal function with filtration rate between 40 - 20 ml/min.
  • Patient should use the classical nephroprotective medication: angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker, or both.

You may not qualify if:

  • Acute urinary tract infection;
  • Urinary infection with tuberculosis bacillus or fungi;
  • Patients with poorly anatomical formations of the urinary tract, polycystic kidney disease and other congenital or acquired kidney diseases.
  • Blood pressure greater than 160 mm Hg systolic and 100 mmHg diastolic, in measurements taken during the last 3 outpatient visits;
  • Who has performed examination with iodinated contrast the last 3 months
  • Use of potentially nephrotoxic drugs;
  • Use of corticosteroid therapy in immunosuppressive doses or more than 0.3 mg/kg/day
  • Inability to obtain vascular access for endovascular procedure
  • Sepsis (defined according to the Society of Critical Care Medicine, American College of Chest Physicians, 1992);
  • Malignancies
  • Autoimmune disorders,
  • Neurodegenerative diseases;
  • Acute heart failure or decompensated;
  • Primary hematologic diseases;
  • Osteopathies reflecting increased risk for spinal puncture;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital Clementino Fraga Filho - UFRJ

Rio de Janeiro, 21941913, Brazil

Location

Related Publications (1)

  • Botelho BF, Barreira AL, Filippo MG, Asensi KD, Faccioli LAP, Dos Santos Salgado AB, de Salles EF, Marques CEC, Silva PL, Dos Santos Goldenberg RC, Maiolino A, Gutfilen B, de Souza SAL, Junior ML, Morales MM. Safety and Biodistribution of an Autologous Bone Marrow-Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study. Stem Cells Int. 2024 Jul 9;2024:2385568. doi: 10.1155/2024/2385568. eCollection 2024.

    PMID: 39015674DERIVED

MeSH Terms

Conditions

Glomerulosclerosis, Focal SegmentalRenal Insufficiency, Chronic

Interventions

Bone Marrow Purging

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeutics

Study Officials

  • Marcelo Marcos Morales, MD,PHD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 30, 2016

First Posted

February 26, 2016

Study Start

June 25, 2015

Primary Completion

February 1, 2018

Study Completion

May 16, 2018

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

BR(1)