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

September 16, 2014 updated by: Dr. Sachin Jamadar, Chaitanya Hospital, Pune

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 4
        • Recruiting
        • Chaitanya Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anant E Bagul, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in degeneration of the Optic nerve with improvement in vision
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in Visual Function
Time Frame: 6 months
6 months
Improvement in idiopathic intra cranial hypertension
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chaitanya Hospital, Pune

Investigators

  • Principal Investigator: ANANT E BAGUL, M.S, Chaitanya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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