We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518127
First Posted: January 25, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rubens Camargo Siqueira, University of Sao Paulo
  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
Age Related Macular Degeneration and Stargartd Other: intravitreal injection of autologous bone marrow stem cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
intravitreal injection of autologous bone marrow stem cells
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Rubens Camargo Siqueira, University of Sao Paulo:

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


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: December 2015
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 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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518127


Locations
Brazil
Rubens Siqueira Research Center
Sao Jose do Rio Preto, SP, Brazil, 15010-100
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rubens C Siqueira, MD,PhD University of Sao Paulo
  More Information

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
First Submitted: September 20, 2011
First Posted: January 25, 2012
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Rubens Camargo Siqueira, University of Sao Paulo:
Macular Degeneration

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