Clinical Trials Logo
  1. Home
  2. Chronic Kidney Disease
  3. NCT02195323
  4. Details
NCT02195323 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Official title:
Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02195323
Other study ID # Royan-Kidney-004
Secondary ID
Status Completed
Phase Phase 1
First received July 17, 2014
Last updated January 3, 2016
Start date April 2014
Est. completion date January 2016

Study information
Verified date November 2015
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics CommitteeIran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date January 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 60 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Royan Institute Tehran

Sponsors (1)
Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary mass formation Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection. 6months Yes
Primary Creatinin Evaluation the rise of creatinin 1 month after cell transplantation. 1 month Yes
Secondary GFR Evaluation the increase of GFR 6 months after cell transplantation with scan isotope . 6months Yes
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4

External Links