Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Phase 1 Study Of Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
1 other identifier
interventional
5
1 country
1
Brief Summary
The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 15, 2010
CompletedSeptember 20, 2011
September 1, 2011
8 months
February 10, 2010
September 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale
3-6 months
Study Arms (1)
Test group
EXPERIMENTALopen-label study of retinitis pigmentosa patients with best-corrected visual acuity (BCVA) worse than 20/200.
Interventions
One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
Eligibility Criteria
You may qualify if:
- diagnosis of retinitis pigmentosa
- logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
You may not qualify if:
- previous ocular surgery other than cataract
- presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
- other ophthalmic disease like glaucoma and uveitis
- previous history of blood disorders like leukemia
- known allergy to fluorescein or indocyanine green
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CPRS
São Jose Do Rio Preto, São Paulo, 15010-100, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubens C Siqueira, MD,PhD
Research Center Rubens Siqueira,Catanduva Medicine School and São Paulo University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 15, 2010
Study Start
May 1, 2009
Primary Completion
January 1, 2010
Study Completion
February 1, 2010
Last Updated
September 20, 2011
Record last verified: 2011-09