Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01736059
First received: July 25, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.


Condition Intervention Phase
Dry Age-related Macular Degeneration
Diabetic Retinopathy
Retina Vein Occlusion
Retinitis Pigmentosa
Hereditary Macular Degeneration
Drug: CD34+ bone marrow stem cells intravitreal
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Incidence and severity of ocular adverse events [ Time Frame: 1 day to 6 months ] [ Designated as safety issue: Yes ]
    As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.


Secondary Outcome Measures:
  • The number of stem cells isolated and injected into the study eye [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.


Other Outcome Measures:
  • Incidence and severity of systemic adverse events [ Time Frame: 1 day to 6 months ] [ Designated as safety issue: Yes ]
    Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.


Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cell treated Drug: CD34+ bone marrow stem cells intravitreal

Detailed Description:

In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years of age
  • visual acuity 20/200 to CF
  • duration of vision loss > 3 months
  • vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
  • the study eye has the worse visual acuity
  • no active eye or systemic disease
  • no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
  • no significant media opacity
  • no coagulopathy or other hematologic abnormality
  • no concurrent immunosuppressive therapy
  • able to keep follow-up for 6 months

Exclusion Criteria:

  • allergy to fluorescein dye
  • other concurrent retinal or optic nerve disease affecting vision
  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: NCT01736059

Contacts
Contact: Susanna S Park, MD PhD 916-734-6074 susanna.park@ucdmc.ucdavis.edu
Contact: Marisa Salvador 916-734-6302 marisa.salvador@ucdmc.ucdavis.edu

Locations
United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Sub-Investigator: Lawrence S Morse, MD PhD         
Sub-Investigator: Jan Nolta, PhD         
Sub-Investigator: Gerhard Bauer         
Sub-Investigator: Carol Richman, MD         
Sub-Investigator: Mehrdad Abedi, MD         
Sub-Investigator: Douglas Taylor, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Susanna s Park, MD PhD University of California Davis Eye Center
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01736059     History of Changes
Other Study ID Numbers: BMSCRetPilot
Study First Received: July 25, 2012
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Stem cells
intravitreal
bone marrow CD34+ cells
retinal disease
clinical trial
autologous

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Retinal Diseases
Retinitis Pigmentosa
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Retinal Degeneration
Retinal Dystrophies
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014