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

Royan Institute

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Biological: Intravenous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02195323

Royan-Kidney-004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

MSC recipient

Experimental group

Description:

The patients with CKD who underwent intravenous injection of MSC.

Treatment:

Biological: Intravenous injection