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

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ClinicalTrials.gov Identifier: NCT01518842
Recruitment Status : Active, not recruiting
First Posted : January 26, 2012
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Rubens Camargo Siqueira, University of Sao Paulo

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

Condition or disease Intervention/treatment Phase
Ischemia Biological: Intravitreal Bone Marrow Stem Cells Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: intravitreal injection of autologous bone marrow stem cells
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in size of FAZ at 48 weeks [ Time Frame: 1 day to 48 weeks ]

Secondary Outcome Measures :
  1. Change in central foveal thickness and best corrected visual acuity at 48 weeks [ Time Frame: 1 day to 48 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT01518842


Locations
Brazil
Rubens Siqueira Research Center
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rubens C Siqueira, MD, PhD Rubens Siqueira Research Center

Publications:
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
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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

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