|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02709876 |
|
Date of registration:
|
26/02/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Autologous Bone Marrow-Derived CD34+, CD133+, and CD271+ Stem Cell Transplantation for Retinitis Pigmentosa
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
April 2014 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02709876 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Jordan
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Retinitis pigmentosa patients diagnosed by ophthalmologists
- Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below
30° central in both eyes.
- Best corrected visual acuity less than 6/120 by Snellen visual acuity chart
Exclusion Criteria:
- Other eye conditions that could mask the interpretation of the results
- Unable to return for follow up
- Underlying diseases including asthma, heart failure, myocardial infarction, liver
failure, renal failure
- Pregnant and lactating women
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Retinitis Pigmentosa
|
|
Intervention(s)
|
|
Biological: Stem Cell Transplantation
|
|
Primary Outcome(s)
|
|
ETDRS Visual acuity change
[Time Frame: 12 months from baseline]
|
|
Secondary Outcome(s)
|
|
Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25)
[Time Frame: 12 months from baseline]
|
|
Color Vision: Ishihara Color Test
[Time Frame: 12 months from baseline]
|
|
Contrast sensitivity: CSV-1000E
[Time Frame: 12 months from baseline]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|