Autoimmune DiseasesPhase 1/2NCT04684602
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
A Phase 1/2 study testing PrimePro™/ PrimeMSK™ in people with Autoimmune Diseases and Cardiovascular Disorders, run by Thomas Advanced Medical LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications
- What is being tested?
- PrimePro™/ PrimeMSK™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 9 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Ability to provide informed consent
- Availability for follow up visits
Who cannot join
- Active or recent malignancy (within last 2 years)
- Pregnancy or breast-feeding
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southern California Hospital at Culver City / Southern California Hospital at Hollywood / Multiple US-based Sub-Investigator Sites
Culver City, California, 92032
Karen Mulholland Angelus, 866-864-7789, info@thomasadvancedmedical.com
Ernst R Von Shwarz, MD PhD, 866 864 7789, info@thomasadvancedmedical.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease, Musculoskeletal Disorders, Neurodegenerative Disorders
- Being tested
- PrimePro™/ PrimeMSK™
- 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
- Medical subject headings
- Autoimmune Diseases, Cardiovascular Diseases, Diabetes Complications, Skin Diseases, Musculoskeletal Diseases, Neurodegenerative Diseases, Nervous System Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimePro™/ PrimeMSK™Biological
Injection via condition specific route of administration.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Autoimmune Diseases | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 2: Cardiovascular Disorders | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 3: Diabetes Complications | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 4: Integumentary Disease | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 5: Musculoskeletal Disorders | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 6: Neurodegenerative Disorders | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 7: Pulmonary Disorders | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 8: Sexual Dysfunction | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 9: Urologic Disorders | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
| Arm 10: Viral Illnesses | Experimental | 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. Receives: Biological: PrimePro™/ PrimeMSK™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Upper Extremity Outcome Instrument
Measured: 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.
Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.
Measured: 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.
COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.
Measured: 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.
Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.
Measured: 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.
Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.
Measured: 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.
Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.
Measured: 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.
Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)
Measured: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start9 Jul 2020
- Primary completion9 Jul 2030 (estimated)
- Study completion9 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Advanced Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HeartStem Institute, NuStem
- Responsible party
- Sponsor
- Investigators
- Ernst R Von Schwarz, MD, PhD, Principal investigator, HeartStem Institute, Southern California Hospital at Culver City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684602
- Sponsor's protocol ID
- ICSS-2020-032
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions
- ClinicalTrials.gov ID
- NCT04684602
- Acronym / sponsor ID
- ICSS-2020-032
- Conditions
- Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease, Musculoskeletal Disorders, Neurodegenerative Disorders
- Keywords
- stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell, Erectile Dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Thomas Advanced Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- HeartStem Institute, NuStem
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 9 Jul 2030 (estimated)
- Study completion
- 9 Dec 2030 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Autoimmune Diseases | Experimental | Biological: PrimePro™/ PrimeMSK™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 2: Cardiovascular Disorders | Experimental | Biological: PrimePro™/ PrimeMSK™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 3: Diabetes Complications | Experimental | Biological: PrimePro™/ PrimeMSK™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 4: Integumentary Disease | Experimental | Biological: PrimePro™/ PrimeMSK™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 5: Musculoskeletal Disorders | Experimental | Biological: PrimePro™/ PrimeMSK™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 6: Neurodegenerative Disorders | Experimental | Biological: PrimePro™/ PrimeMSK™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 7: Pulmonary Disorders | Experimental | Biological: PrimePro™/ PrimeMSK™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 8: Sexual Dysfunction | Experimental | Biological: PrimePro™/ PrimeMSK™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 9: Urologic Disorders | Experimental | Biological: PrimePro™/ PrimeMSK™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 10: Viral Illnesses | Experimental | Biological: PrimePro™/ PrimeMSK™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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Ability to provide informed consent
- Availability for follow up visits
Key exclusion criteria (3 listed)
- Active or recent malignancy (within last 2 years)
- Pregnancy or breast-feeding
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrimePro™/ PrimeMSK™Injection via condition specific route of administration. | Biological | Arm 10: Viral Illnesses, 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 |
Primary outcome
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.
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
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.
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.
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.
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.
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No. Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ernst R Von Schwarz, MD, PhD principal investigator
HeartStem Institute, Southern California Hospital at Culver City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PrimePro™/ PrimeMSK™ in people with Autoimmune Diseases and Cardiovascular Disorders, run by Thomas Advanced Medical LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul C Bogaardt, PhD(c), MSc, MBA (866 864 7789, paul@thomasadvancedmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.