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. It is Self Funded (Patients' Own Funding) Clinical Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01834079

Acronym

OND

Enrollment

Registered

2013-04-17

Start date

2014-09-30

Completion date

2016-07-31

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Atrophy

Keywords

Optic Atrophy,Stem cell therapy

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 .

Interventions

BIOLOGICALSTEM 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Reduction in degeneration of the Optic nerve with improvement in vision	6 Months

Secondary

Measure	Time frame
Increase in Visual Function	6 months
Improvement in idiopathic intra cranial hypertension	6 Months

Countries

India

Contacts

Primary ContactSachin P Jamadar, D.Ortho

sac2751982@gmail.com+918888788880

Backup ContactSmita S Bhoyar, B.A.M.S.PGCR

drsmitabhoyar@rediff.com9372620569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026