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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01914913 |
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Date of registration:
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31/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
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Scientific title:
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An Open Labeled Clinical Study to Evaluate the Safety and Efficacy OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Retinitis Pigmentosa. It is Self Funded (Patients' Own Funding) Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01914913 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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ANANT E BAGUL, MS ORTHO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chaitanya Hospital |
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Name:
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Sachin P Jamadar, D.Ortho |
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Address:
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Telephone:
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918888788880 |
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Email:
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sac2751982@gmail.com |
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Affiliation:
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Name:
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Sachin P Jamadar, D ORTHO |
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Address:
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Telephone:
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+918888788880 |
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Email:
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sac2751982@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-65
- Diagnosis of retinitis pigmentosa
- 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:
- Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and
Syphilis
- Women who are pregnant or lactating
- Complications of diabetic retinopathy.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Biological: BMMNCs
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Primary Outcome(s)
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visual acuity
[Time Frame: 1 YEAR]
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Secondary ID(s)
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CSCC/BMRP/2013//01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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