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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PrimePro™/ PrimeMSK™

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Arm 1: Autoimmune Diseases

Arm 2: Cardiovascular Disorders

Arm 3: Diabetes Complications

Arm 4: Integumentary Disease

Arm 5: Musculoskeletal Disorders

Arm 6: Neurodegenerative Disorders

Arm 7: Pulmonary Disorders

Arm 8: Sexual Dysfunction

Arm 9: Urologic Disorders

Arm 10: Viral Illnesses

Arm 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 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.

Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.

Upper Extremity Outcome Instrument

Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.

Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.

Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.

COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.

Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.

Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.

Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.

Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.

Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.

Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.

Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.

Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)

Secondary Outcome Measures

Full Information

NCT ID

NCT04684602

First Posted

December 2, 2020

Last Updated

April 27, 2022

Sponsor

Thomas Advanced Medical LLC

Collaborators

HeartStem Institute, NuStem

1. Study Identification

Unique Protocol Identification Number

NCT04684602

Brief Title

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

Official Title

Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 9, 2020 (Actual)

Primary Completion Date

July 9, 2030 (Anticipated)

Study Completion Date

December 9, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Advanced Medical LLC

Collaborators

HeartStem Institute, NuStem

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Autoimmune Diseases

Arm Type

Experimental

Arm 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.

Arm Title

Arm 2: Cardiovascular Disorders

Arm Type

Experimental

Arm 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.

Arm Title

Arm 3: Diabetes Complications

Arm Type

Experimental

Arm 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.

Arm Title

Arm 4: Integumentary Disease

Arm Type

Experimental

Arm 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.

Arm Title

Arm 5: Musculoskeletal Disorders

Arm Type

Experimental

Arm 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.

Arm Title

Arm 6: Neurodegenerative Disorders

Arm Type

Experimental

Arm 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.

Arm Title

Arm 7: Pulmonary Disorders

Arm Type

Experimental

Arm 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.

Arm Title

Arm 8: Sexual Dysfunction

Arm Type

Experimental

Arm 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.

Arm Title

Arm 9: Urologic Disorders

Arm Type

Experimental

Arm 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.

Arm Title

Arm 10: Viral Illnesses

Arm Type

Experimental

Arm 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.

Intervention Type

Biological

Intervention Name(s)

PrimePro™/ PrimeMSK™

Intervention Description

Injection via condition specific route of administration.

Primary Outcome Measure Information:

Title

Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.

Description

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.

Time Frame