Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876017
• Other study ID #: CSCC/BMCRF/2013//01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 8, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: 918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• Intravenous transfer of Autologous (BMMNCs)
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous (BMMNCs)

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune,	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	pain intensity by VAS	Assessment of pain by visual analogue score	3 month	No
Secondary	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	No
Secondary	Improvement in subjective global assessment		3 month	Yes
Secondary	the incident of uremia and dialysis requirement		6 month	Yes