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Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration (AMDCELL)

Primary Purpose

Age Related Macular Degeneration and Stargartd

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

intravitreal injection of autologous bone marrow stem cells

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration and Stargartd focused on measuring Macular Degeneration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female AMD and Stargartd patients 18 to 80 years old, inclusive.
In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
ETDRS best corrected visual acuity of 60 letters or worse in the study eye.

Exclusion Criteria:

Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
Choroidal neovascularization due to a cause other than AMD.
In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.

Sites / Locations

Rubens Siqueira Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell group

Arm Description

intravitreal injection of autologous bone marrow stem cells

Outcomes

Primary Outcome Measures

ETDRS Visual acuity change

Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT01518127

First Posted

September 20, 2011

Last Updated

July 18, 2017

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01518127

Brief Title

Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration

Acronym

AMDCELL

Official Title

Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2015 (Actual)

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

The purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.

Detailed Description

A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration and Stargartd patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of bone marrow stem cells: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of Bone Marrow Stem Cells: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or choroidal neovascularization; 4) increase > 5 letters on BCVA

6. Conditions and Keywords

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

Age Related Macular Degeneration and Stargartd

Keywords

Macular Degeneration

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

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stem cell group

Arm Type

Experimental

Arm Description

intravitreal injection of autologous bone marrow stem cells

Intervention Type

Other

Intervention Name(s)

intravitreal injection of autologous bone marrow stem cells

Other Intervention Name(s)

Cell Therapy

Intervention Description

intravitreal injection of autologous bone marrow stem cells

Primary Outcome Measure Information:

Title

ETDRS Visual acuity change

Description

Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment

Time Frame

Day 1 to Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female AMD and Stargartd patients 18 to 80 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD ETDRS best corrected visual acuity of 60 letters or worse in the study eye. Exclusion Criteria: Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study. Choroidal neovascularization due to a cause other than AMD. In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period. Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration. Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye. Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye. Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation. Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubens C Siqueira, MD,PhD

Organizational Affiliation

University of Sao Paulo

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

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Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration

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