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. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Optic Atrophy
Biological: STEM CELL THERAPY
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • Reduction in degeneration of the Optic nerve with improvement in vision [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Intrathecal transplantation of autologous stem cells

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834079

Contacts
Contact: Sachin P Jamadar, D.Ortho +918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 4
Contact: Sachin P Jamadar, D.Ortho    8888788880    sac2751982@gmail.com   
Contact: Smita S Bhoyar, BAMS.PGCR    9372620569    drsmitabhoyar@rediffmail.com   
Principal Investigator: ANANT E BAGUL, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01834079     History of Changes
Other Study ID Numbers: 00104
Study First Received: February 26, 2013
Last Updated: April 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
Optic Atrophy,Stem cell therapy

Additional relevant MeSH terms:
Nervous System Diseases
Optic Atrophy
Optic Nerve Diseases
Atrophy
Cranial Nerve Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014