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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Retinitis Pigmentosa

Treatments

Biological: BMMNCs

Study type

Interventional

Funder types

Other

Identifiers

NCT01914913

CSCC/BMRP/2013//01

Details and patient eligibility

About

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 .

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.