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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Rubens Camargo Siqueira, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01518127
First received: September 20, 2011
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Other: intravitreal injection of autologous bone marrow stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bone Marrow-Derived Stem Cells in Patients With Advanced Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • ETDRS Visual acuity change [ Time Frame: Day 1 to Day 365 ] [ Designated as safety issue: Yes ]
    Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment


Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stem cell group
intravitreal injection of autologous bone marrow stem cells
Other: intravitreal injection of autologous bone marrow stem cells
intravitreal injection of autologous bone marrow stem cells
Other Name: Cell Therapy

Detailed Description:

A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration 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

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female AMD patients 55 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518127

Contacts
Contact: Rubens C Siqueira, MD,PhD 55(17)32140896 rubenssiqueira@terra.com.br

Locations
Brazil
Rubens Siqueira Research Center Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Contact: Rubens C Siqueira, MD,PhD    55(17)32140896    rubenssiqueira@terra.com.br   
Principal Investigator: Rubens C Siqueira, MD,PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rubens C Siqueira, MD,PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Rubens Camargo Siqueira, MD,PhD - Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01518127     History of Changes
Other Study ID Numbers: Sao Paulo University
Study First Received: September 20, 2011
Last Updated: January 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Sao Paulo:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014