Back to results

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

Primary Purpose

Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Intravitreal Bone Marrow Stem Cells

About this trial

This is an interventional treatment trial for Ischemia focused on measuring ischemic retinopathy, stem cell,bone marrow

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rubens Siqueira Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

test group intravitreal stem cell

Arm Description

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

Outcomes

Primary Outcome Measures

Change in size of FAZ at 48 weeks

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01518842

First Posted

January 22, 2012

Last Updated

October 15, 2018

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01518842

Brief Title

Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Acronym

RetinaCell

Official Title

Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia

Keywords

ischemic retinopathy, stem cell,bone marrow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

intravitreal injection of autologous bone marrow stem cells

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

test group intravitreal stem cell

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Intravitreal Bone Marrow Stem Cells

Intervention Description

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 Measure Information:

Title

Change in size of FAZ at 48 weeks

Time Frame

1 day to 48 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

1 day to 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubens C Siqueira, MD, PhD

Organizational Affiliation

Rubens Siqueira Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rubens Siqueira Research Center

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15010-100

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

24954079

Citation

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.

Results Reference

background

Learn more about this trial

Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

We'll reach out to this number within 24 hrs