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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04684602
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : April 29, 2022
Sponsor:
Collaborators:
HeartStem Institute
NuStem
Information provided by (Responsible Party):
Thomas Advanced Medical LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Cardiovascular Disorders Diabetes Complications Integumentary Disease Musculoskeletal Disorders Neurodegenerative Disorders Neurologic Disorders Pulmonary Disorders Sexual Dysfunction Urologic Disorders Viral Illness Biological: PrimePro™/ PrimeMSK™ Phase 1 Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-center, prospective, open label clinical trial. It will include 5000 patients suffering acute and chronic conditions under 10 different categories. Patients will undergo a single treatment with a biological tissue allograft and will be followed for 12 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : July 9, 2030
Estimated Study Completion Date : December 9, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Autoimmune Diseases
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 2: Cardiovascular Disorders
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiovascular disorders and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 3: Diabetes Complications
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for diabetes complications. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 4: Integumentary Disease
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for integumentary diseases and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 5: Musculoskeletal Disorders
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic and musculoskeletal conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 6: Neurodegenerative Disorders
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic and neurodegenerative disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 7: Pulmonary Disorders
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 8: Sexual Dysfunction
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for sexual dysfunction conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 9: Urologic Disorders
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Experimental: Arm 10: Viral Illnesses
Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for viral illnesses. Outcomes will be compared to results in peer-reviewed literature for several conditions.
 Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684602


Contacts
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Contact: Paul C Bogaardt, PhD(c), MSc, MBA 866 864 7789 paul@thomasadvancedmedical.com
Contact: Karen Mulholland Angelus 866 864 7789 karen@thomasadvancedmedical.com

Locations
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United States, California
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites Recruiting
Culver City, California, United States, 92032
Contact: Karen Mulholland Angelus    866-864-7789    info@thomasadvancedmedical.com   
Contact: Ernst R Von Shwarz, MD PhD    866 864 7789    info@thomasadvancedmedical.com   
Sponsors and Collaborators
Thomas Advanced Medical LLC
HeartStem Institute
NuStem
Investigators
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Principal Investigator: Ernst R Von Schwarz, MD, PhD HeartStem Institute, Southern California Hospital at Culver City
More Information
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Responsible Party: Thomas Advanced Medical LLC
ClinicalTrials.gov Identifier: NCT04684602    
Other Study ID Numbers: ICSS-2020-032
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Thomas Advanced Medical LLC:
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
Nervous System Diseases
Alzheimer Disease
Musculoskeletal Diseases
Cardiovascular Diseases
Immune System Diseases
Neuromuscular Diseases
Covid-19
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Lung Diseases
Nervous System Diseases
Neurodegenerative Diseases
Cardiovascular Diseases
Skin Diseases
 Diabetes Complications
Autoimmune Diseases
Immune System Diseases
Diabetes Mellitus
Endocrine System Diseases
Respiratory Tract Diseases