Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official 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

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Biological: BMMNCs


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BMMNCs<br>BMMNCs | Biological: BMMNCs<br>* Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | Electronic Visual Acuity (EVA) technology | 1 YEAR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow, retinitis pigmentosa, stem cell, BMMNC