Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Ischemia Clinical Trial

— RetinaCell  

Official title:

Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01518842
• Other study ID #: Siqueira Research Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2011
• Est. completion date: January 2020

Study information

• Verified date: October 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Rubens Siqueira Research Center	Sao Jose do Rio Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Siqueira RC, Messias A, Gurgel VP, Simões 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in size of FAZ at 48 weeks		1 day to 48 weeks
Secondary	Change in central foveal thickness and best corrected visual acuity at 48 weeks		1 day to 48 weeks