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

NCT ID: NCT01914913

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-11-30

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.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMMNCs

BMMNCs

Group Type OTHER

BMMNCs

Intervention Type BIOLOGICAL

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

Interventions

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BMMNCs

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

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chaitanya Hospital, Pune

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sachin Jamadar

Co -investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANANT E BAGUL, MS ORTHO

Role: PRINCIPAL_INVESTIGATOR

Chaitanya Hospital

Locations

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Chaitanya Hospital

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sachin P Jamadar, D.Ortho

Role: CONTACT

918888788880

Facility Contacts

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Sachin P Jamadar, D ORTHO

Role: primary

+918888788880

Other Identifiers

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CSCC/BMRP/2013//01

Identifier Type: -

Identifier Source: org_study_id

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