Posterior Pole (Retinitis Pigmentosa, Macular degeneration, Diabetic retinopathy, Glaucoma)
Angeles Health International offers Stem Cell Application for several eye diseases including retinitis pigmentosa, macular degeneration, diabetic retinopathy and glaucoma. Treatment uses adipose-derived stem cells that are harvested from the patient’s body. A Center of Excellence, Angeles hospital prides itself on the highest standards of treatment and investigative research. Here is the inclusion and exclusion criteria for stem cell application to treat eye diseases.
• Males and Females between Age 18 and 80 years.
For AMD patients:
• Patients with nonexudative AMD
• Visual acuity in the study eye > 20/60
For Glaucoma patients:
• Unilateral or bilateral primary open angle glaucoma
• At least 3 reliable visual field testings
• Treated intraocular pressure < 21 mmHg,
• Visual field mean deviation MD For Retinitis Pigmentosa patients:
• Diagnosis of retinitis pigmentosa
• Logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse For Diabetic RetinopathyRetinopaty
• Diagnosis of Proliferative Diabetic Retinopaty with no haemovitreus
• BCVA of 1.0 (Snellen equivalent, 20/200) or worse
• At the time of the screening/enrollment visit #1, patients meeting ANY ONE of the following criteria will be excluded from the study.
• 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 fat transfer 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 and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBVcAg and HBV-sAg, then 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;
• Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5.
• 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.
• 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.