Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration
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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Withdrawn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
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Sponsor:
Bioheart, Inc.
Information provided by (Responsible Party):
Bioheart, Inc.
Tracking Information | |||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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 | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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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
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Withdrawn | ||
Actual Enrollment ICMJE |
0 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | ||
Current Responsible Party | Bioheart, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Bioheart, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
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 |