Status:
UNKNOWN
Investigation of Therapeutic Efficacy and Safety of UMSCs for the Management of Retinitis Pigmentosa (RP)
Lead Sponsor:
Jinnah Burn and Reconstructive Surgery Centre, Lahore
Collaborating Sponsors:
The Layton Rahmatullah Benevolent Trust (LRBT) Free Eye Hospital, Township Lahore.
Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
Conditions:
Retinitis Pigmentosa (RP)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Retinitis pigmentosa (RP) is the most common hereditary retinal disorder (accounts for 20% of children attending blind schools in Pakistan) which causes degeneration of rod and cone photoreceptors. Ro...
Detailed Description
Isolation and characterization of human umbilical cord derived mesenchymal stem cells (UMSCs): The culturing and characterization of UMSCs will be performed as documented by Ali and colleagues. Briefl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04763369
Start Date
February 1 2021
End Date
June 1 2022
Last Update
February 21 2021
Active Locations (1)
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1
Stem Cell laboratory, Jinnah Burn & Reconstructive Surgery Centre
Lahore, Punjab Province, Pakistan, 54550