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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Optic Atrophy

Treatments

Biological: STEM CELL THERAPY

Study type

Interventional

Funder types

Other

Identifiers

NCT01834079

00104

Details and patient eligibility

About

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.

Full 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 .

Enrollment

24 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.