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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914913

Enrollment

Registered

2013-08-02

Start date

2014-09-30

Completion date

2016-11-30

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Keywords

retinitis pigmentosa, Bone marrow, stem cell, BMMNC

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.

Interventions

BIOLOGICALBMMNCs

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
visual acuity	1 YEAR	Electronic Visual Acuity (EVA) technology

Countries

India

Contacts

Primary ContactSachin P Jamadar, D.Ortho

sac2751982@gmail.com918888788880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026