Stroke Clinical Trial
Official title:
Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions
To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.
Status | Not yet recruiting |
Enrollment | 5000 |
Est. completion date | March 20, 2029 |
Est. primary completion date | March 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 and over. 2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms. 3. Competent to understand the study protocol and provide voluntary informed consent. 4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back/Neck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure. Exclusion Criteria: 1. Active Cancer 2. Pregnancy, Lactating 3. Severe Clotting disorder 4. Myocardial Infarction less than six months ago. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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R3 Stem Cell |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disabilities of Arm, Shoulder, Hand Questionnaire (DASH) | Upper Extremity Outcome Instrument | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Sexual Health Inventory for Men Questionnaire (SHIM) | Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Kidney Disease and Quality of Life Questionnaire (KDQOL) | Renal Function Outcome Instrument. Raw, precoded numeric values for 36 items are transformed linearly to a 0 to 100 range, with higher scores reflecting better quality of life. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Assessment of Quality of Life Questionnaire (AQOL) | General Health Outcome Instrument. Each instrument is used to derive a simple psychometric score for health related quality of life (HRQoL) and to provide profile scores on the different dimensions or items of the descriptive systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Clinical Chronic Obstructive Pulmonary Disease Questionnaire | COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Mini Mental State Examination (MMSE) | Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | O'Leary/Sant Questionnaire | Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Oswestry Low Back Pain Disability Questionnaire | Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function. | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. | |
Primary | Western Ontario and McMaster Osteoarthritis Index (WOMAC) | Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). | Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months and 120 months. |
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