Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

Phase 1CompletedNCT02195323

Royan Institute7 enrolled

Overview

This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

Intravenous injectionBIOLOGICAL

Intravenous injection of bone marrow derived MSC in patients with CKD.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and Female * CKD symptoms * CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2 * Patient's age between 25 - 60 years * Ability to understand and willingness to sign consent from Exclusion Criteria: * Pregnant or lactating * Basis disease such as diabetes, malignancy and autoimmune * Unable to follow post-operative exercise regimen or return for evaluations

Locations (1)

Royan Institute

Tehran, Iran

Outcomes

Primary Outcomes

mass formation

Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.

Time frame: 6months

Creatinin

Evaluation the rise of creatinin 1 month after cell transplantation.

Time frame: 1 month

Secondary Outcomes

GFR

Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .

Time frame: 6months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.