This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.
This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions. This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses. Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,000
Injection via condition specific route of administration.
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
Culver City, California, United States
RECRUITINGAssessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.
General Health Outcome Instrument used to derive a simple psychometric score for health related quality of life which provides scores on various dimensions or items describing the systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.
Upper Extremity Outcome Instrument
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)
Time frame: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
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