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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune Identifier:
First received: July 31, 2013
Last updated: September 16, 2014
Last verified: September 2014
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 .

Condition Intervention Phase
Retinitis Pigmentosa Biological: BMMNCs Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • visual acuity [ Time Frame: 1 YEAR ]
    Electronic Visual Acuity (EVA) technology

Estimated Enrollment: 15
Study Start Date: September 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Biological: BMMNCs
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01914913

Contact: Sachin P Jamadar, D.Ortho 918888788880

Chaitanya Hospital Recruiting
Pune,, Maharashtra, India, 411030
Contact: Sachin P Jamadar, D ORTHO    +918888788880   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
  More Information

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune Identifier: NCT01914913     History of Changes
Other Study ID Numbers: CSCC/BMRP/2013//01
Study First Received: July 31, 2013
Last Updated: September 16, 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
retinitis pigmentosa
Bone marrow
stem cell

Additional relevant MeSH terms:
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn processed this record on August 22, 2017