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

Phase 1

• Conditions: Optic Atrophy
• Interventions: Biological: STEM CELL THERAPY

• Registration Number: NCT01834079
• Lead Sponsor: Chaitanya Hospital, Pune

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 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 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 .

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEM CELL	STEM CELL THERAPY	intra thecal injection of MNC stem cell therapy

Primary Outcome Measures

Name	Time	Method
Reduction in degeneration of the Optic nerve with improvement in vision	6 Months

Secondary Outcome Measures

Name	Time	Method
Increase in Visual Function	6 months
Improvement in idiopathic intra cranial hypertension	6 Months

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India