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

Primary Purpose

Optic Atrophy

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
STEM CELL THERAPY
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Atrophy focused on measuring Optic Atrophy,Stem cell therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEM CELL

Arm Description

intra thecal injection of MNC stem cell therapy

Outcomes

Primary Outcome Measures

Reduction in degeneration of the Optic nerve with improvement in vision

Secondary Outcome Measures

Increase in Visual Function
Improvement in idiopathic intra cranial hypertension

Full Information

First Posted
February 26, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01834079
Brief Title
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Atrophy
Keywords
Optic Atrophy,Stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM CELL
Arm Type
Other
Arm Description
intra thecal injection of MNC stem cell therapy
Intervention Type
Biological
Intervention Name(s)
STEM CELL THERAPY
Other Intervention Name(s)
Intrathecal transplantation of autologous stem cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in degeneration of the Optic nerve with improvement in vision
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Increase in Visual Function
Time Frame
6 months
Title
Improvement in idiopathic intra cranial hypertension
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Smita S Bhoyar, B.A.M.S.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediff.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, M.S
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
4
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D.Ortho
Phone
8888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Smita S Bhoyar, BAMS.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediffmail.com
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS

12. IPD Sharing Statement

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

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