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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

Conditions

Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease, Musculoskeletal Disorders, Neurodegenerative Disorders

Being tested

PrimePro™/ PrimeMSK™

Keywords

stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell, Erectile Dysfunction, Heart Diseases, Mental Disorders, Neurocognitive Disorders, Neurodegenerative Diseases, Central Nervous System Diseases, Tauopathies, Brain Diseases, Dementia, Disease, Cardiomyopathies, Urologic Diseases, Peripheral Nervous System Diseases

Medical subject headings

Autoimmune Diseases, Cardiovascular Diseases, Diabetes Complications, Skin Diseases, Musculoskeletal Diseases, Neurodegenerative Diseases, Nervous System Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• PrimePro™/ PrimeMSK™Biological

  Injection via condition specific route of administration.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Assessment 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

2. Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.

   Upper Extremity Outcome Instrument

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

3. 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

4. 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

5. 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

6. 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

7. 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.

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

8. 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)

   Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Dec 2020
2. Study start9 Jul 2020
3. Primary completion9 Jul 2030 (estimated)
4. Study completion9 Dec 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.