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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
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Brief Summary:
Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Biological: BMMNCs Phase 1 Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
BMMNCs
BMMNCs
Biological: BMMNCs
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)




Primary Outcome Measures :
  1. visual acuity [ Time Frame: 1 YEAR ]
    Electronic Visual Acuity (EVA) technology



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com

Locations
India
Chaitanya Hospital Recruiting
Pune,, Maharashtra, India, 411030
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01914913     History of Changes
Other Study ID Numbers: CSCC/BMRP/2013//01
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
retinitis pigmentosa
Bone marrow
stem cell
BMMNC

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn