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

April 27, 2022 updated by: Thomas Advanced Medical LLC

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Culver City, California, United States, 92032
        • Recruiting
        • Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.
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.
Injection via condition specific route of administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Upper Extremity Outcome Instrument
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.
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
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.
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
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.
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
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.
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
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.
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
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.
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)
Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2020

Primary Completion (ANTICIPATED)

July 9, 2030

Study Completion (ANTICIPATED)

December 9, 2030

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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