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

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914913
• Other study ID #: CSCC/BMRP/2013//01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 31, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: 918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune,	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	Electronic Visual Acuity (EVA) technology	1 YEAR	No