Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
Purpose
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
- Neurodegenerative Disorders
- Neurologic Disorders
- Pulmonary Disorders
- Sexual Dysfunction
- Urologic Disorders
- Viral Illness
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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Recruiting Locations
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
Culver City, California 92032
Culver City, California 92032
More Details
- NCT ID
- NCT04684602
- Status
- Recruiting
- Sponsor
- Thomas Advanced Medical LLC
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.