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

Sponsor
Chaitanya Hospital, Pune (Other)
Overall Status
Unknown status
CT.gov ID
NCT01834079
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
22
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: STEM CELL THERAPY
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2016
Anticipated Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: STEM CELL

intra thecal injection of MNC stem cell therapy

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
Other Names:
  • Intrathecal transplantation of autologous stem cells

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in degeneration of the Optic nerve with improvement in vision [6 Months]

    Secondary Outcome Measures

    1. Increase in Visual Function [6 months]

    2. Improvement in idiopathic intra cranial hypertension [6 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chaitanya Hospital Pune Maharashtra India 4

    Sponsors and Collaborators

    • Chaitanya Hospital, Pune

    Investigators

    • Principal Investigator: ANANT E BAGUL, M.S, CHAITANYA HOSPITAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
    ClinicalTrials.gov Identifier:
    NCT01834079
    Other Study ID Numbers:
    • 00104
    First Posted:
    Apr 17, 2013
    Last Update Posted:
    Sep 17, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
    Optic Atrophy,Stem cell therapy
    Additional relevant MeSH terms:
    Optic Atrophy
    Optic Nerve Diseases
    Atrophy

    Study Results

    No Results Posted as of Sep 17, 2014