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Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bioheart, Inc.
ClinicalTrials.gov Identifier:
NCT02024269
First received: December 17, 2013
Last updated: September 15, 2015
Last verified: September 2015
  Purpose
This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC) implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via needle injection into the eye.

Condition Intervention
Dry Macular Degeneration Biological: Adipose Derived Stem Cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Injected Intravitreal in Dry Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Bioheart, Inc.:

Primary Outcome Measures:
  • frequency and nature of adverse events [ Time Frame: 6 months ]
  • Visual Field analysis (10-2) [ Time Frame: 6 months ]
    Visual field testing can be performed clinically by keeping the subject's gaze fixed while presenting objects at various places within their visual field.

  • Visual Acuity Measurements [ Time Frame: 6 months ]
    Visual acuity is a measure of the spatial resolution of the visual processing system. VA is tested by requiring the person whose vision is being tested to identify so-called optotypes - stylized letters, Landolt rings or other patterns - on a chart from a set viewing distance.


Secondary Outcome Measures:
  • Intraocular pressure [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adipose Stem Cells Biological: Adipose Derived Stem Cells

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females between Age 50 and 90 years
  • Patients with dry AMD
  • Visual acuity in the study eye <20200 (equal to or worse than 20/200)

Exclusion Criteria:

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Inability to undergo syringe liposuction procedure or have any medical problems that contraindicate the procedure.
  • Life expectancy < 6 months due to concomitant illnesses.
  • Vitrectomized eyes
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease. . If patients have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis, an expert will be consulted as to patient eligibility based on the patient's infectious status
  • Any illness which might affect a patient's survival over the follow-up period
  • Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Patients with severe coagulation disorders
  • Systolic blood pressure (supine) ≤90 mmHg;
  • Resting heart rate > 100 bpm;
  • Active clinical infection being treated by antibiotics within one week of enrollment.
  • Cerebrovascular accident within 6 months prior to study entry
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • Severe COPD or severe asthma that would contraindicate surgery
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
  • Unwilling and/or not able to give written informed consent.
  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: NCT02024269

Locations
United States, Florida
Bioheart
Sunrise, Florida, United States
Sponsors and Collaborators
Bioheart, Inc.
  More Information

Responsible Party: Bioheart, Inc.
ClinicalTrials.gov Identifier: NCT02024269     History of Changes
Other Study ID Numbers: ADI-US-AMD-001
Study First Received: December 17, 2013
Last Updated: September 15, 2015

Keywords provided by Bioheart, Inc.:
macular degeneration
stem cells
adipose stem cells

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

ClinicalTrials.gov processed this record on August 18, 2017