Clinical Study to Evaluate Safety and Efficacy of Stem Cell Therapy in Retinitis Pigmentosa

This study is not yet open for participant recruitment.
Verified October 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01914913
First received: July 31, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.Stem cell therapy is used as therapy for this condition .


Condition Intervention Phase
Retinitis Pigmentosa
Biological: Transfer of Mesenchymal Stem Cell ( MSCs )
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy Mesenchymal Stem Cell in Retinitis Pigmentosa.

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • visual acuity [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
    Electronic Visual Acuity (EVA) technology


Estimated Enrollment: 15
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mesenchymal stem cell
transfer of Mesenchymal Stem Cell ( MSCs )
Biological: Transfer of Mesenchymal Stem Cell ( MSCs )
Intervention therapy , Total 6 doses ,in 30 days ,in 7days interval ,transfer of Bone marrow derived Mesenchymal Stem Cell ( MSCs ).

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 stem cell therapy in RP.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914913

Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitanya Hospital Not yet recruiting
Pune,, Maharashtra, India, 411030
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01914913     History of Changes
Other Study ID Numbers: CSCC/BMRP/2013//01
Study First Received: July 31, 2013
Last Updated: October 8, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
retinitis pigmentosa
Bone marrow
Mesenchymal stem cell

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014