Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

NCT01518842 | Unknown DMC

• 1 other identifier: Siqueira Research Center
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemia

Keywords

ischemic retinopathy, stem cell,bone marrow

Outcome Measures

Primary Outcomes (1)

• Change in size of FAZ at 48 weeks

  1 day to 48 weeks

Secondary Outcomes (1)

• Change in central foveal thickness and best corrected visual acuity at 48 weeks

  1 day to 48 weeks

Study Arms (1)

test group intravitreal stem cell

EXPERIMENTAL

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

Interventions

Intravitreal Bone Marrow Stem Cells BIOLOGICAL

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.

test group intravitreal stem cell

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Rubens Siqueira Research Center

São José do Rio Preto, São Paulo, 15010-100, Brazil

Location

Related Publications (1)

• Siqueira RC, Messias A, Gurgel VP, Simoes BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. No abstract available.

  PMID: 24954079 BACKGROUND

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubens C Siqueira, MD, PhD

  Rubens Siqueira Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD - Principal Investigator

Model Details: intravitreal injection of autologous bone marrow stem cells

Study Record Dates

• First Submitted: January 22, 2012
• First Posted: January 26, 2012
• Study Start: September 1, 2011
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2020
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

BR (1)