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

Phase 1

• Conditions: Retinitis Pigmentosa
• Interventions: Biological: BMMNCs

• Registration Number: NCT01914913
• Lead Sponsor: 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 .

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 Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMMNCs	BMMNCs	BMMNCs

Primary Outcome Measures

Name	Time	Method
visual acuity	1 YEAR	Electronic Visual Acuity (EVA) technology

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune,, Maharashtra, India