Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure

Study Overview
=================
Brief Summary
-----------------
This Study is single arm, single center trial to check the safety and efficacy of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF

Detailed Description
-----------------
Chronic kidney failure, also called chronic kidney disease, describes the gradual loss of kidney function. Kidney failure is a medical condition in which kidneys fail to filter metabolic wastes and toxins out of the body and a series of symptoms will be developed .It is common, frequently un recognised and often exists together with other conditions (for example, cardiovascular disease and diabetes). When advanced, it also carries a higher risk of mortality. The risk of developing CKD(Chronic Kidney diseases ) increases with increasing age, and some conditions that coexist with CKD become more severe as kidney dysfunction advances CKD can progress to established renal failure in a small but significant percentage of people. This classification divides CKD into five stages. Stages 3-5 may be defined by glomerular filtration rate (GFR) alone, whereas stages 1 and 2 also require the presence of persistent proteinuria, albuminuria or haematuria, or structural abnormalities. Stem cells have two important characteristics that distinguish them from other types of cells. First, they are unspecialized cells that renew themselves for long periods through cell division. The second is that under certain physiologic or experimental conditions, they can be induced to become cells with special function such as the beating cells of heart muscle or the insulin- producing cells of the pancreas as well as the neurons of brain.So our approach is to prove safety and efficacy of stem cell in CRF

Official Title
-----------------
An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Chronic Renal Failure Patients. It is Self Funded (Patients' Own Funding) Clinical Trial

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Biological: Intravenous transfer of Autologous (BMMNCs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age limit: 18 -65 willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation. To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study. willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol. Exclusion Criteria: Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc. Women who are pregnant or lactating Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders. Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores. Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis Hemoglobin level below 7g % estimated glomerular filtration rate (eGFR) of < 45ml/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BMMNC<br>Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) | Biological: Intravenous transfer of Autologous (BMMNCs)<br>* Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous (BMMNCs)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintain or demonstrate improvement in laboratory values. | • Hematological (Complete blood count (CBC) Complete blood count (CBC) urea(mg/dL), creatinine (mg/dL), plasma calcium(mg/dL), plasma alkaline phosphatase (U/L),plasma phosphorus (mg/dL), plasma cholesterol(mg/dL), plasma HDL-cholesterol (mg/dL), plasma triglyceride (mg/dL), hematocrit (%) and erythrocyte(M/_L) values were evaluated before and at the end of the study.) | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity by VAS | Assessment of pain by visual analogue score | 3 month | 
| Improvement in SF36(Short form 36) score | The SF36, a short-form QoL scoring system with 36 items, is a self-administered questionnaire that was constructed to fill the gap between much more lengthy surveys and relatively coarse single-item measures of the QoL | 3 month | 
| Improvement in subjective global assessment |  | 3 month | 
| the incident of uremia and dialysis requirement |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEM CELL, CKD, CRF