Covid19Phase 1NCT04573270
Mesenchymal Stem Cells for the Treatment of COVID-19
A Phase 1 study testing PrimePro in people with Covid19 and Prophylaxis, run by Thomas Advanced Medical LLC at 1 site in United States.
Trial summary
This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Prophylaxis
- What is being tested?
- PrimePro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 1 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who cannot join
- Active or recent malignancy (within last 2 years)
- Inability to provide informed consent
- Current enrollment in any other COVID-19 treatment study
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Hospital at Culver City / Southern California Hospital at Hollywood
Culver City, California, 92032
About this study
Official title: A Pilot Phase Study Evaluating the Effects of a Single Mesenchymal Stem Cell Injection in Patients With Suspected or Confirmed COVID-19 Infection and Healthcare Providers Exposed to Coronavirus Patients
This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.
Read the detailed description
Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure.
This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness.
A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.
- Conditions
- Covid19, Prophylaxis
- Being tested
- PrimePro, Placebo
- Keywords
- stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeProBiological
Intravenous Injection
PlaceboOther
Intravenous Injection
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patients Experimental | Experimental | 13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. Receives: Biological: PrimePro |
| COVID-19 Patients Placebo | Placebo comparator | 13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. Receives: Other: Placebo |
| Healthcare Providers Experimental | Experimental | 7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. Receives: Biological: PrimePro |
| Healthcare Providers Placebo | Placebo comparator | 7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rates
Survival Rate in COVID-19 infected patients admitted to hospital for complications
Measured: 30 Days
Contraction Rates
Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start24 Apr 2020
- Primary completion20 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is a randomized assignment, double-blind, placebo-controlled, multi-arm, multi-site study located at Southern California Hospitals at Culver City and Hollywood.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Advanced Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HeartStem Institute
- 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
- NCT04573270
- Sponsor's protocol ID
- Pro00043080
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase Study Evaluating the Effects of a Single Mesenchymal Stem Cell Injection in Patients With Suspected or Confirmed COVID-19 Infection and Healthcare Providers Exposed to Coronavirus Patients
- ClinicalTrials.gov ID
- NCT04573270
- Acronym / sponsor ID
- Pro00043080
- Conditions
- Covid19, Prophylaxis
- Keywords
- stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Advanced Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- HeartStem Institute
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Oct 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 double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.
Detailed description
Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure.
This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness.
A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This study is a randomized assignment, double-blind, placebo-controlled, multi-arm, multi-site study located at Southern California Hospitals at Culver City and Hollywood.
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patients Experimental | Experimental | Biological: PrimePro13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
| COVID-19 Patients Placebo | Placebo comparator | Other: Placebo13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
| Healthcare Providers Experimental | Experimental | Biological: PrimePro7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
| Healthcare Providers Placebo | Placebo comparator | Other: Placebo7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Active or recent malignancy (within last 2 years)
- Inability to provide informed consent
- Current enrollment in any other COVID-19 treatment study
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 |
|---|---|---|
| PrimeProIntravenous Injection | Biological | COVID-19 Patients Experimental, Healthcare Providers Experimental |
| PlaceboIntravenous Injection | Other | COVID-19 Patients Placebo, Healthcare Providers Placebo |
Primary outcome
Survival Rates
Time frame: 30 Days
Survival Rate in COVID-19 infected patients admitted to hospital for complications
Contraction Rates
Time frame: 30 Days
Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- 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. This study is not recruiting at the moment.
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 study testing PrimePro in people with Covid19 and Prophylaxis, 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 2 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: finished, as of the sponsor's last update on 5 Oct 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rates (time frame: 30 Days). The study lists 2 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 5 Oct 2020.