Clinical trial NCT01834079: Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Optic Atrophy
Keywords: Optic Atrophy,Stem cell therapy
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in degeneration of the Optic nerve with improvement in vision
timeFrame: 6 Months
Secondary outcomes:
measure: Increase in Visual Function
timeFrame: 6 months
measure: Improvement in idiopathic intra cranial hypertension
timeFrame: 6 Months
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References: