Status:
UNKNOWN
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Optic Atrophy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted for 36 months in pa...
Detailed Description
Optic Nerve Diseases: Conditions which produce injury or dysfunction of the second cranial or optic nerve, which is generally considered a component of the central nervous system. Damage to optic nerv...
Eligibility Criteria
Inclusion
- Patient Should suffer from Optic Nerve diseases Like Diabetic Retinopathy, retinal pigmentation
- age in between 18 to 50
- Willingness to undergo Bone Marrow derived autologous cell therapy.
- Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the require Informed consent form(ICF) for the study.
- A ability and willingness to regular visit to hospital for protocol and follow up.
Exclusion
- Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect including Syphilis, clinically relevant polyneuropathy) etc.
- History of Life threatening Allergic or immune- mediated reaction
- Haemodynamically Unstable.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01834079
Start Date
September 1 2014
End Date
July 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitanya Hospital
Pune, Maharashtra, India, 4