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

Bioheart

Status

Withdrawn

Conditions

Dry Macular Degeneration

Treatments

Biological: Adipose Derived Stem Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT02024269

ADI-US-AMD-001

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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.