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NCT Number: NCT04684602

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

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Key information

Conditions

Autoimmune Diseases Alzheimer Disease Brain Diseases COVID-19 Cardiomyopathies Cardiovascular Diseases Cardiovascular Disorders Central Nervous System Diseases Coronaviridae Infections Coronavirus Infections Dementia Diabetes Complications Diabetes Mellitus Disease Endocrine System Diseases Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Heart Diseases Immune System Diseases Infections Integumentary Disease Lung Diseases Male Urogenital Diseases Mental Disorders Musculoskeletal Diseases Musculoskeletal Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurodegenerative Disorders Neurologic Disorders Neuromuscular Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pneumonia Pneumonia, Viral Pulmonary Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Skin Diseases Skin and Connective Tissue Diseases Tauopathies Urogenital Diseases Urologic Diseases Urologic Disorders Viral Illness Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites

Culver City, California, 92032, United States

Location status: Recruiting

Location contact

Ernst R Von Shwarz, MD PhD

CONTACT

[email protected]

866 864 7789

Karen Mulholland Angelus

CONTACT

[email protected]

866-864-7789

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Ability to provide informed consent
  • Availability for follow up visits

Exclusion criteria

  • Active or recent malignancy (within last 2 years)
  • Pregnancy or breast-feeding
  • Inability to provide informed consent

Treatment and study plan

PrimePro™/ PrimeMSK™

Biological

Injection via condition specific route of administration.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Mulholland Angelus

CONTACT

[email protected]

866 864 7789

Paul C Bogaardt, PhD(c), MSc, MBA

CONTACT

[email protected]

866 864 7789

Sponsors and collaborators

Lead sponsor

Thomas Advanced Medical LLC

Industry

Collaborators

  • HeartStem Institute
  • NuStem

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 24, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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