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

This study is currently recruiting participants.
Verified April 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01834079
First received: February 26, 2013
Last updated: April 15, 2013
Last verified: April 2013

February 26, 2013
April 15, 2013
March 2011
March 2014   (final data collection date for primary outcome measure)
Reduction in degeneration of the Optic nerve with improvement in vision [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01834079 on ClinicalTrials.gov Archive Site
  • Increase in Visual Function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Improvement in idiopathic intra cranial hypertension [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease.

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.

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 .

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Optic Atrophy
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 Name: Intrathecal transplantation of autologous stem cells
STEM CELL
intra thecal injection of MNC stem cell therapy
Intervention: Biological: STEM CELL THERAPY
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
April 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact: Sachin P Jamadar, D.Ortho +918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com
India
 
NCT01834079
00104
Yes
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
Chaitanya Hospital, Pune
Not Provided
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
Chaitanya Hospital, Pune
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP