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Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy (RetinaCell)

This study is currently recruiting participants.
Verified January 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Rubens Camargo Siqueira, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01518842
First received: January 22, 2012
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.


Condition Intervention Phase
Ischemia
 Biological: Intravitreal Bone Marrow Stem Cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in size of FAZ at 48 weeks [ Time Frame: 1 day to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in central foveal thickness and best corrected visual acuity at 48 weeks [ Time Frame: 1 day to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test group intravitreal stem cell

Open-label study of Ischemic Retinopathy patients with best-corrected visual acuity (BCVA) worse than 20/200.

Intervention: Biological: intravitreal injection of autologous bone marrow stem cells

 Biological: Intravitreal Bone Marrow Stem Cells
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.
Other Name: Intravitreal Bone Marrow Stem Cells

Detailed Description:

Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Ischemic Retinopathy
  • Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography
  • logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
  • Able (in the Investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518842

Contacts
Contact: Rubens C Siqueira, MD,PhD 55(17)32345858 rubenssiqueira@terra.com.br

Locations
Brazil
Rubens Siqueira Research Center Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Contact: Rubens c Siqueira, mD,PhD     55(17)32140896     rubenssiqueira@terra.com.br    
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rubens C Siqueira, MD, PhD Rubens Siqueira Research Center
  More Information

No publications provided

Responsible Party: Rubens Camargo Siqueira, MD,PhD - Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01518842     History of Changes
Other Study ID Numbers: Siqueira Research Center
Study First Received: January 22, 2012
Last Updated: January 25, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
ischemic retinopathy, stem cell,bone marrow

Additional relevant MeSH terms:
Ischemia
Retinal Diseases
Pathologic Processes
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013