Status:
UNKNOWN
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01876017
Start Date
September 1 2014
End Date
December 1 2016
Last Update
September 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chaitanya Hospital
Pune, Maharashtra, India, 411009