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

Part of paid clinical trials in Culver City, California.

Sponsor
Thomas Advanced Medical LLC
Study ID
NCT04684602
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Diseases
  • Cardiovascular Disorders
  • Diabetes Complications
  • Integumentary Disease
  • Musculoskeletal Disorders
  • Neurodegenerative Disorders
  • Neurologic Disorders
  • Pulmonary Disorders
  • Sexual Dysfunction
  • Urologic Disorders
  • Viral Illness

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PrimePro™/ PrimeMSK™ — BIOLOGICAL
    Injection via condition specific route of administration.

Study Details

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.

Key Dates

Start date
Jul 9, 2020
Status verified
Apr 2022
Primary completion
Jul 9, 2030
Completion
Dec 9, 2030

Study Design

Enrollment
5,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator SitesCulver CityCalifornia92032
Karen Mulholland Angelus
[email protected]
866-864-7789
Ernst R Von Shwarz, MD PhD
[email protected]
866 864 7789

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By research site
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites· Culver City, CA

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