Investigation of Therapeutic Efficacy and Safety of UMSCs for the Management of Retinitis Pigmentosa (RP)
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|ClinicalTrials.gov Identifier: NCT04763369|
Recruitment Status : Unknown
Verified February 2021 by Prof. Dr. Sheikh Riazuddin, Jinnah Burn and Reconstructive Surgery Centre, Lahore.
Recruitment status was: Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa (RP)||Biological: Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa Biological: Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Group 1: Five (5) subjects will be treated by injecting UMSCs in sub-tenon space of eye.
Group 2: Five (5) subjects will be treated by suprachoroidal injection of UMSCs .
From two subjects in group 1 & 2 will not be treated 24 hrs apart. Patients will be randomized in a 1:1 ratio (Sub-tenon injection of UMSCs : Suprachoroidal injection of UMSCs).
Note: In total, twenty five patients will be subjected to cell injection for each of group 1 & 2.
|Masking:||None (Open Label)|
|Official Title:||Investigation of Therapeutic Efficacy and Safety of Umbilical Cord Derived Mesenchymal Stem Cells (UMSCs) for the Management of Retinitis Pigmentosa (RP)|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Sub-tenon injection group
In total twenty five subjects will be treated by injecting UMSCs in sub-tenon space of eye.
Biological: Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa
Cultured stem cells will be injected in the sub-tenon space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
Experimental: Suprachoroidal injection group
A total of twenty five subjects will be treated by suprachoroidal injection of UMSCs.
Biological: Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa
Cultured stem cells will be injected in the suprachoroidal space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
- Evaluation of safety related adverse ocular events including immune response [ Time Frame: Baseline to day 360 ]No significant side effects in stem cell treated subjects
- Ophthalmic examination for best-corrected visual acuity (BCVA) using early treatment of diabetic retinopathy study (ETDRS) chart [ Time Frame: Baseline to day 360 ]Change in best corrected visual acuity (BCVA)
- Measurement of electrical activity/function of retina using Electroretinography (ERG) test [ Time Frame: Baseline to day 360 ]Change in electrical response/function of various cell types of retina
- Evaluation of outer retinal thickness using Optical Coherence Tomography (OCT) imaging test [ Time Frame: Baseline to day 360 ]Alteration in retinal thickness
- Examination of retinal damage by Fundus Photography [ Time Frame: Baseline to day 360 ]Change in retinal Fundus image
- Evaluation of visual field sensitivity using perimeter [ Time Frame: Baseline to day 360 ]Change in visual field sensitivity
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients who will be voluntarily participated for UMSCs injection for the treatment of RP.
- Patients who will be able to adhere to the study follow-up and protocol requirements.
- Individuals with age ranges from 18 years to 70 years will be included.
- Patients with best corrected visual acuity (BCVA) from 50 letters to 110 letters or <20/50 in the ETDRS chart testing (Topcon CC-100 XP, Japan).
- Mean deviation values ranging between -33.0 and - 5.0 dB with compass visual field analysis (threshold 24-2, Sita Standard, Stimulus 3-white).
- Diagnosis of any phenotypic or genotypic variation of RP, confirmed by clinical history, fundus appearance, visual field, electroretinogram and genetic mutation analysis.
- Presence of cataracts or other media opacity that might affect the visual field, mean deviation, or electroretinogram recordings.
- Presence of another ocular disease except RP (i.e., uveitis, strabismus, glaucoma) that causes visual field and optic disc changes.
- Presence of any systemic disorder that may affect visual functions. This includes diabetes, neurological disorders, and uncontrolled systemic hypertension.
- Smokers will be excluded from the study.
- Individuals who underwent ocular surgery except cataract extraction will be considered as excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763369
|Contact: Sheikh Riazuddin, PhDemail@example.com|
|Contact: Muhammad Ali, PhDfirstname.lastname@example.org|
|Stem Cell laboratory, Jinnah Burn & Reconstructive Surgery Centre||Recruiting|
|Lahore, Punjab, Pakistan, 54550|
|Contact: Muhammad Ali, PhD +923218429448 email@example.com|
|Principal Investigator:||Sheikh Riazuddin, PhD||Jinnah Burn & Reconstructive Surgery Center, Lahore|
|Principal Investigator:||Zaheer-ud-Din A Qazi, consultant||The Layton Rahmatullah Benevolent Trust (LRBT)|
|Responsible Party:||Prof. Dr. Sheikh Riazuddin, Distinguished National Professor, Jinnah Burn and Reconstructive Surgery Centre, Lahore|
|Other Study ID Numbers:||
|First Posted:||February 21, 2021 Key Record Dates|
|Last Update Posted:||February 21, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Stem cells treatment
Eye Diseases, Hereditary
Genetic Diseases, Inborn