Recruiting
Phase 1
Phase 2

Mesenchymal Stem Cells

Sponsor:

Thomas Advanced Medical LLC

Code:

NCT04684602

Conditions

Autoimmune Diseases

Cardiovascular Disorders

Diabetes Complications

Integumentary Disease

Musculoskeletal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrimePro™/ PrimeMSK™

Study Details

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.

Conditions

Autoimmune Diseases

Cardiovascular Disorders

Diabetes Complications

Integumentary Disease

Musculoskeletal Disorders

Study ID

NCT04684602

Start date

Jul 9, 2020

Status verified date

Apr, 2022

Completion date

Dec 9, 2030

Anticipated

Primary completion date

Jul 9, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

PrimePro™/ PrimeMSK™

Injection via condition specific route of administration.

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

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

866 864 7789paul@thomasadvancedmedical.com

Karen Mulholland Angelus

866 864 7789karen@thomasadvancedmedical.com

Locations

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

Recruiting

Culver City, California, United States, 92032

Contacts

Karen Mulholland Angelus

866-864-7789info@thomasadvancedmedical.com

Ernst R Von Shwarz, MD PhD

866 864 7789info@thomasadvancedmedical.com

More Information

Sponsor

Thomas Advanced Medical LLC

Last update posted

Apr 29, 2022

Last verified

Apr, 2022

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
  • Nervous System Diseases
  • Alzheimer Disease
  • Musculoskeletal Diseases
  • Cardiovascular Diseases
  • Immune System Diseases
  • Neuromuscular Diseases
  • Covid-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Advanced Medical LLC on 2022-04-29.