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Recruitment Status : Withdrawn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
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|Condition or disease||Intervention/treatment||Phase|
|Dry Macular Degeneration||Biological: Adipose Derived Stem Cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
|Experimental: Adipose Stem Cells||
Biological: Adipose Derived Stem Cells
- 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.
- Intraocular pressure [ Time Frame: 6 months ]
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|Ages Eligible for Study:||50 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024269
|United States, Florida|
|Sunrise, Florida, United States|
|Responsible Party:||Bioheart, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 31, 2013 Key Record Dates|
|Last Update Posted:||September 16, 2015|
|Last Verified:||September 2015|
adipose stem cells