Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

BIOLOGICAL

PrimePro™/ PrimeMSK™

Injection via condition specific route of administration.

Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.