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

Optic Atrophy Clinical Trial

— OND  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834079
• Other study ID #: 00104
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 26, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: +918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nervous System Diseases
• Optic Atrophy
• Optic Nerve Diseases

Intervention

Biological:
• STEM CELL THERAPY
Autologous stem cells(MNCs ) intra thecal .Intra thecal transplantation of single arm autologous MNCs 100 millions per dose in 3 divided doses at interval of 7 days,Intrathecal/Intravenous .Follow up will be taken to three Months or as required

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in degeneration of the Optic nerve with improvement in vision		6 Months	Yes
Secondary	Increase in Visual Function		6 months	Yes
Secondary	Improvement in idiopathic intra cranial hypertension		6 Months	Yes