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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01834079
Other study ID # 00104
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received February 26, 2013
Last updated September 16, 2014
Start date September 2014
Est. completion date July 2016

Study information

Verified date September 2014
Source Chaitanya Hospital, Pune
Contact Sachin P Jamadar, D.Ortho
Phone +918888788880
Email sac2751982@gmail.com
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
India Chaitanya Hospital Pune Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in degeneration of the Optic nerve with improvement in vision 6 Months Yes
Secondary Increase in Visual Function 6 months Yes
Secondary Improvement in idiopathic intra cranial hypertension 6 Months Yes
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