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

NCT02195323 | Completed Phase 1 DMC

• 1 other identifier: Royan-Kidney-004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

autologous bone marrow mesenchymal stem cells chronic kidney disease

Outcome Measures

Primary Outcomes (2)

• mass formation

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

  6months

• Creatinin

  Evaluation the rise of creatinin 1 month after cell transplantation.

  1 month

Secondary Outcomes (1)

• GFR

  6months

Study Arms (1)

MSC recipient

EXPERIMENTAL

The patients with CKD who underwent intravenous injection of MSC.

Biological: Intravenous injection

Interventions

Intravenous injection BIOLOGICAL

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

Also known as: Intravenous transplantation

MSC recipient

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating
• Basis disease such as diabetes, malignancy and autoimmune
• Unable to follow post-operative exercise regimen or return for evaluations

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Injections, Intravenous

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

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

  STUDY DIRECTOR

• Atieh Makhloogh, MD

  Mazandaran University of Medical Sciences, Mazandaran, Iran

  STUDY DIRECTOR

• Reza Moghadasali, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2015-11

Locations

IR (1)