Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Optic Nerve Disease
OND
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 17, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 17, 2014
September 1, 2014
1.8 years
February 26, 2013
September 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in degeneration of the Optic nerve with improvement in vision
6 Months
Secondary Outcomes (2)
Increase in Visual Function
6 months
Improvement in idiopathic intra cranial hypertension
6 Months
Study Arms (1)
STEM CELL
OTHERintra thecal injection of MNC stem cell therapy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaitanya Hospital
Pune, Maharashtra, 4, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANANT E BAGUL, M.S
CHAITANYA HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CO-Investigator
Study Record Dates
First Submitted
February 26, 2013
First Posted
April 17, 2013
Study Start
September 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 17, 2014
Record last verified: 2014-09