Clinical Trial: Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease. It is Self Funded (Patients' Own Funding) Clinical Trial

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 patients with optic nerve diseases.

Detailed Summary: 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 nerve fibres may occur at or near their origin in the retina, at the optic disk, or in the nerve, optic chiasm, optic tract, or lateral geniculate nuclei. Clinical manifestations may include decreased visual acuity and contrast sensitivity, impaired color vision, and an afferent papillary defect. primary out put of clinical study is to measures Improvement in visual loss and improvement in idiopathic intra cranial.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 .
Sponsor: Chaitanya Hospital, Pune

Current Primary Outcome: Reduction in degeneration of the Optic nerve with improvement in vision [ Time Frame: 6 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Increase in Visual Function [ Time Frame: 6 months ]
  • Improvement in idiopathic intra cranial hypertension [ Time Frame: 6 Months ]


Original Secondary Outcome: Same as current

Information By: Chaitanya Hospital, Pune

Dates:
Date Received: February 26, 2013
Date Started: September 2014
Date Completion: July 2016
Last Updated: September 16, 2014
Last Verified: September 2014