A Phase 1/2 interventional study of STEM CELL THERAPY in Optic Atrophy, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.
Sponsored by Chaitanya Hospital, Pune · Phase 1/2, Interventional, and Treatment
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 .
16 studies on the registry are indexed under Optic Atrophy; 3 are open to participants now.
This study's planned enrollment of 24 is close to the median of 23 across 10 interventional studies indexed under Optic Atrophy.
Browse Optic Atrophy studies →Chaitanya Hospital, Pune is the lead sponsor of 16 studies on the registry; none are open to participants now.
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The human immunodeficiency virus, which weakens the immune system.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Intrathecal transplantation of autologous stem cells
Reduction in degeneration of the Optic nerve with improvement in vision
Time frame: 6 Months
Increase in Visual Function
Time frame: 6 months
Improvement in idiopathic intra cranial hypertension
Time frame: 6 Months
The record gives a start of Sep 2014, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Chaitanya Hospital, Pune