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

Thomas Advanced Medical

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Biological: PrimePro™/ PrimeMSK™

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04684602

ICSS-2020-032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,000 participants in 10 patient groups

Arm 1: Autoimmune Diseases

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 2: Cardiovascular Disorders

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 3: Diabetes Complications

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 4: Integumentary Disease

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 5: Musculoskeletal Disorders

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 6: Neurodegenerative Disorders

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 7: Pulmonary Disorders

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 8: Sexual Dysfunction

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 9: Urologic Disorders

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™

Arm 10: Viral Illnesses

Experimental group

Description:

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.

Treatment:

Biological: PrimePro™/ PrimeMSK™