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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
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.
Biological: PrimePro™/ PrimeMSK™
Injection via condition specific route of administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Advanced Medical LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HeartStem Institute
NuStem

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2030

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICSS-2020-032

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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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