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

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.
 
ClinicalTrials.gov Identifier: NCT02024269
Recruitment Status : Withdrawn
First Posted : December 31, 2013
Last Update Posted : September 16, 2015
Sponsor:
Information provided by (Responsible Party):
Bioheart, Inc.

Tracking Information
First Submitted Date  ICMJE December 17, 2013
First Posted Date  ICMJE December 31, 2013
Last Update Posted Date September 16, 2015
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
Intraocular pressure [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dry Macular Degeneration
Intervention  ICMJE Biological: Adipose Derived Stem Cells
Study Arms  ICMJE Experimental: Adipose Stem Cells
Intervention: Biological: Adipose Derived Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2013)
100
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02024269
Other Study ID Numbers  ICMJE ADI-US-AMD-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioheart, Inc.
Study Sponsor  ICMJE Bioheart, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bioheart, Inc.
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP