- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024269
Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration
September 15, 2015 updated by: Bioheart, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Sunrise, Florida, United States
- Bioheart
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Adipose Stem Cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
frequency and nature of adverse events
Time Frame: 6 months
|
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.
|
6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraocular pressure
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
June 1, 2017
Study Registration Dates
First Submitted
December 17, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (ESTIMATE)
December 31, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 16, 2015
Last Update Submitted That Met QC Criteria
September 15, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADI-US-AMD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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