Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
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|ClinicalTrials.gov Identifier: NCT01914913|
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was: Recruiting
First Posted : August 2, 2013
Last Update Posted : September 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Biological: BMMNCs||Phase 1 Phase 2|
This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .
Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
- visual acuity [ Time Frame: 1 YEAR ]Electronic Visual Acuity (EVA) technology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914913
|Contact: Sachin P Jamadar, D.Orthofirstname.lastname@example.org|
|Pune,, Maharashtra, India, 411030|
|Contact: Sachin P Jamadar, D ORTHO +918888788880 email@example.com|
|Principal Investigator: Anant E Bagul, MS,Ortho|
|Principal Investigator:||ANANT E BAGUL, MS ORTHO||Chaitanya Hospital|