Chronic Renal FailurePhase 1/2NCT01876017
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
A Phase 1/2 study testing Intravenous transfer of Autologous (BMMNCs) in people with Chronic Renal Failure, run by Chaitanya Hospital, Pune at 1 site in India.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Intravenous transfer of Autologous (BMMNCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411009
Sachin P Jamadar, D ORTHO, +918888788880, sac2751982@gmail.com
Anant E Bagul, MS,Ortho
About this study
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
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
Read the 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
- Conditions
- Chronic Renal Failure
- Being tested
- Intravenous transfer of Autologous (BMMNCs)
- Keywords
- CRF, STEM CELL, CKD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous transfer of Autologous (BMMNCs)Biological
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous (BMMNCs)
| Study group | Role | What they receive |
|---|---|---|
| BMMNC | Other | Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) Receives: Biological: Intravenous transfer of Autologous (BMMNCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 3 month
Secondary outcomes (4)
pain intensity by VAS
Assessment of pain by visual analogue score
Measured: 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
Measured: 3 month
Improvement in subjective global assessment
Measured: 3 month
the incident of uremia and dialysis requirement
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaitanya Hospital, Pune
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sachin Jamadar, Chaitanya Hospital, Pune
- Investigators
- ANANT E BAGUL, MS ORTHO, Principal investigator, Chaitanya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876017
- Sponsor's protocol ID
- CSCC/BMCRF/2013//01
- Status last verified
- Sep 2014
- First submitted
- 8 Jun 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01876017
- Acronym / sponsor ID
- CSCC/BMCRF/2013//01
- Conditions
- Chronic Renal Failure
- Keywords
- CRF, STEM CELL, CKD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMMNC | Other | Biological: Intravenous transfer of Autologous (BMMNCs)Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous transfer of Autologous (BMMNCs)Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous (BMMNCs) | Biological | BMMNC |
Primary outcome
Maintain or demonstrate improvement in laboratory values.
Time frame: 3 month
• 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.)
4 secondary outcomes
pain intensity by VAS
Time frame: 3 month
Improvement in SF36(Short form 36) score
Time frame: 3 month
Improvement in subjective global assessment
Time frame: 3 month
the incident of uremia and dialysis requirement
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANANT E BAGUL, MS ORTHO principal investigator
Chaitanya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous transfer of Autologous (BMMNCs) in people with Chronic Renal Failure, run by Chaitanya Hospital, Pune at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sachin P Jamadar, D.Ortho (918888788880, sac2751982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintain or demonstrate improvement in laboratory values. (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.