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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: December 17, 2013
• First Posted Date: December 31, 2013
• Last Update Posted Date: September 16, 2015
• Study Start Date: December 2013
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: December 30, 2013): Intraocular pressure [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Dry Macular Degeneration
• Intervention: Biological: Adipose Derived Stem Cells

Study Arms

Experimental: Adipose Stem Cells

Intervention: Biological: Adipose Derived Stem Cells

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 15, 2015): 0
• Original Estimated Enrollment (submitted: December 30, 2013): 100
• Estimated Study Completion Date: June 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02024269
• Other Study ID Numbers: ADI-US-AMD-001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bioheart, Inc.
• Study Sponsor: Bioheart, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bioheart, Inc.
• Verification Date: September 2015