Effects of mesenchymal stem cell therapy in patients with chronic kidney disease

Not Applicable

Conditions: Chronic Kidney Disease (CKD).
Kidney damage with decreased GFR
N18.1, N18

Registration Number: IRCT201204248349N1

Lead Sponsor: Presidency of the Islamic Republic of Iran, Vice-Presidency for Science and Technology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 15

Inclusion Criteria

Inclusion Criteria:
1-CKD patient
2- GFR between 15-30 mml/min
3- No serious underlying disease
4- Availability of previous medical records for creatinin and GFR
5- Age between 18-65 years
The necessary information will be given to patients before enrollment and patient will sign the consent form.

Exclusion Criteria

1- Serious mental disorders (suicide history, major depression)
2- Patients who cannot come for regular visits
3- Less than one year survival
4- Patients who use immunosuppressive drug
5- Pregnancy
6- Congestive Heart Failure (CHF)
7- Malignancy
8- Coagulation disorders
9- Uncontrolled hypertension
10- Positive virology tests
11- Infection or osteomyelitis in bone marrow aspiration site
12- Hb<8 g/dL, platelet <100,000

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure. Timepoint: Before and every two months after intervention up to one year. Method of measurement: Mercury sphygmomanometer.;Serum creatinin. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: Autoanalyser.;Glomerular filtration rate (GFR). Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: MDRD formula.;Urine creatinin. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: 24 h urine collection.;Urine Protein. Timepoint: Baseline and every two months after intervention up to one year. Method of measurement: 24 h urine collection.

Secondary Outcome Measures

Name	Time	Method
eed to dialysis. Timepoint: Baseline and every two months after intervention. Method of measurement: Serum creatinin.;Stem cell injection complications. Timepoint: Baseline and every two months after intervention. Method of measurement: Biochemical and clinical assessment of patients.