- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684602
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Paul C Bogaardt, PhD(c), MSc, MBA
- Phone Number: 866 864 7789
- Email: paul@thomasadvancedmedical.com
Study Contact Backup
- Name: Karen Mulholland Angelus
- Phone Number: 866 864 7789
- Email: karen@thomasadvancedmedical.com
Study Locations
-
-
California
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Culver City, California, United States, 92032
- Recruiting
- Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
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Contact:
- Karen Mulholland Angelus
- Phone Number: 866-864-7789
- Email: info@thomasadvancedmedical.com
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Contact:
- Ernst R Von Shwarz, MD PhD
- Phone Number: 866 864 7789
- Email: info@thomasadvancedmedical.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Immune System Diseases
- Cardiovascular Diseases
- Covid-19
- Erectile Dysfunction
- Nervous System Diseases
- Dementia
- stem cells
- Alzheimer Disease
- Central Nervous System Diseases
- Musculoskeletal Diseases
- Urologic Diseases
- Neurodegenerative Diseases
- Neuromuscular Diseases
- MSC
- Mental Disorders
- Mesenchymal Stem Cell
- Disease
- Brain Diseases
- Heart Diseases
- umbilical cord stem cells
- Neurocognitive Disorders
- stem cell therapy
- Peripheral Nervous System Diseases
- Tauopathies
- Cardiomyopathies
- amniotic stem cells
- Medicinal Signaling Cell
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICSS-2020-032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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