Mesenchymal Stem Cells for Various Chronic and Acute Conditions
This study is looking at the safety and effectiveness of a stem cell therapy called PrimePro™/PrimeMSK™ for people with a variety of long-term (chronic) and sudden (acute) health conditions. These conditions include autoimmune diseases, heart problems, diabetes complications, skin conditions, and muscle and bone disorders. To see if the treatment is working, researchers will measure changes in your quality of life, arm/shoulder/hand disability, and erectile function over 6 and 12 months. You may be able to join if you are 18 or older and can attend follow-up visits, but not if you have had cancer recently, are pregnant or breastfeeding, or cannot give informed consent. The study aims to enroll up to 5000 participants.
- Study design
- This is an interventional study, meaning participants will receive a treatment. It is a multi-site study, but the phase and specific structure (like whether it's randomized) are not specified.
- What's involved
- You would receive an injection of PrimePro™/PrimeMSK™ and need to be available for follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life, disability, and erectile function will be assessed at 6 and 12 months after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ernst R Von Schwarz, MD, PhD · PRINCIPAL_INVESTIGATOR · HeartStem Institute, Southern California Hospital at Culver City
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months 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.
- Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Upper Extremity Outcome Instrument
- Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
- Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
- Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
- Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
- Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
- Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)