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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 4, 2014
Last verified: September 2014
  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.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: 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 OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) 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: 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
BMMNCs
BMMNCs
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.

  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
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 ClinicalTrials.gov identifier: NCT01914913

Contacts
Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com

Locations
India
Chaitanya Hospital 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: September 4, 2014
Health Authority: India: Institutional Review Board

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

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 September 16, 2014