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.
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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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
50 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.