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

NCT ID: NCT02195323

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSC recipient

The patients with CKD who underwent intravenous injection of MSC.

Group Type EXPERIMENTAL

Intravenous injection

Intervention Type BIOLOGICAL

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

Interventions

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Intravenous injection

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Intravenous transplantation

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of regenerative medicine department &cell therapy center of Royan Institute

Atieh Makhloogh, MD

Role: STUDY_DIRECTOR

Mazandaran University of Medical Sciences, Mazandaran, Iran

Reza Moghadasali, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

Related Links

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Other Identifiers

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Royan-Kidney-004

Identifier Type: -

Identifier Source: org_study_id

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