Covid19Phase 1/2ULSCNCT04494386

Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS

A Phase 1/2 study testing Umbilical Cord Lining Stem Cells (ULSC) in people with Covid19 and Corona Virus Infection, run by Restem, LLC. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Corona Virus Infection, SARS-CoV Infection
What is being tested?: Umbilical Cord Lining Stem Cells (ULSC)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 23 Dec 2020to 12 May 2023
Phase: Phase 1/2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult, male or female, age ≥18 years old
Diagnosis of the presence of the COVID-19 agent with confirmation of COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent test.
Patient with diagnosis of COVID-related ARDS, classified as either:
Not requiring mechanical ventilation (NV) or
Requiring mechanical ventilation (V).
According to Berlin Definition of Acute Respiratory Distress Syndrome (ARDS), patients will be categorized based on degrees of hypoxemia [arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2)]:

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Mild ARDS: 200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg
Moderate ARDS: 100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg
Severe ARDS: PaO2/FIO2 ≤ 100 mm Hg
Patient who has exhibited deterioration in condition during the past 72 hours prior to the informed consent.
Patient receiving standard of care in-hospital therapy, including appropriate critical oxygenation, fluid, and hemodynamic support as indicated clinically.
Patient or responsible family member or surrogate signs informed consent.

Who cannot join

Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).
Active cancer or prior diagnosis of cancer within the past year; however, patients with basal and squamous cell cancer of skin will not be excluded.
Organ transplant recipient.
Chronic renal failure being treated by renal replacement therapy (dialysis) before development of COVID-19.
Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up.
Pregnancy or lactation; a negative pregnancy test between screening and day 1 (before administration of treatment) will be required of women with childbearing potential, and they will be advised of the requirement to use an effective means of contraception. A woman is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Miami Baptist Hospital
Miami, Florida, 33176
Sanford Research
Sioux Falls, South Dakota, 57105

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About this study

Official title: Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19

Read the detailed description

The Phase 1, open-label, non-controlled trial in this study will investigate the safety of intravenous (IV) infusion of ULSC in a total of 20 patients with COVID-19-related ARDS that will include patients that are not intubated and not on a ventilator (NV) and patients that are intubated and on a ventilator (V) for respiratory support. Separate cohorts of each group (NV and V) will receive either a single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval).

The Phase 2a randomized and placebo-controlled trial in this study will investigate the potential efficacy of IV infusion of ULSC in a total of 40 patients with COVID-19-related ARDS that will all be EITHER NV or V; the determination of that eligibility criterion and the ULSC dosing regimen will be based on Phase 1 data of safety and tolerability. Phase 2a will evaluate EITHER single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval). The randomization will be 3:1 with 30 patients receiving investigational product (ULSC) and 10 patients receiving placebo (carrier control).

Conditions: Covid19, Corona Virus Infection, SARS-CoV Infection, ARDS, Coronavirus
Being tested: Umbilical Cord Lining Stem Cells (ULSC), Placebo (carrier control)
Medical subject headings: COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Umbilical Cord Lining Stem Cells (ULSC)Biological
Also called Umbilical Cord Lining Stem Cells (ULSC), type of mesenchymal stem cells (MSC) derived from single donor umbilical cord tissue for allogeneic use
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
Placebo (carrier control)Other
IV infusion of carrier control consisting of sterile saline for injection

Study groups in NCT04494386
Study group	Role	What they receive
ULSC in Phase 1 Open Label	Experimental	Intravenous (IV) infusion of ULSC in 20 patients with COVID-19 ARDS: In Phase 1, two separate cohorts per group will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The first cohort enrolled will receive the single dose; the next cohort enrolled will be administered the repeat dose regimen. Receives: Biological: Umbilical Cord Lining Stem Cells (ULSC)
ULSC in Phase 2a Randomized	Experimental	Intravenous (IV) infusion of ULSC in 30 patients with COVID-19 ARDS: In Phase 2a, 30 patients assigned ULSC will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The ULSC dosing regimen will be chosen based on Phase 1 data of safety and tolerability. Receives: Biological: Umbilical Cord Lining Stem Cells (ULSC)
Placebo in Phase 2a Randomized	Placebo comparator	Intravenous (IV) infusion of carrier control in 10 patients with COVID-19 ARDS: In Phase 2a, 10 patients assigned Placebo will receive either single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval) of carrier control; the dosing regimen will correspond to that of the experimental arm. Receives: Other: Placebo (carrier control)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Dose Limiting Toxicity (DLT)
Number of subjects with a DLT event during or within 24 hours after ULSC infusion
[Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]
Measured: 24 hours
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
Measured: 1 week
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up
Measured: 1 month
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up
Measured: 12 months

Secondary outcomes (10)

Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Measured: 1 month
Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio
Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator
Measured: 1 month
Number of ventilator-free days (VFD)
Number of ventilator-free days (VFD) in period of 1 month from study treatment
Measured: 1 month
Changes in Complete Blood Count (CBC) with differential from baseline
Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood glucose (mg/dL) from baseline
Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of sodium (mEq/L) from baseline
Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of potassium (mEq/L) from baseline
Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline
Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of alanine transaminase (ALT; U/L) from baseline
Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measured: 1 month, 2 months, 3 months, 6 months, and 12 months
Change in Urinalysis (UA) from baseline
Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 202012 May 2023

First posted31 Jul 2020
Study start23 Dec 2020
Primary completion12 May 2023
Study completion12 May 2023

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04494386
Sponsor's protocol ID: ULSC-CV-01
Acronym: ULSC
Status last verified: Apr 2024
First submitted: 24 Jul 2020
Last updated: 9 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19
ClinicalTrials.gov ID: NCT04494386
Acronym / sponsor ID: ULSC / ULSC-CV-01
Conditions: Covid19, Corona Virus Infection, SARS-CoV Infection, ARDS, Coronavirus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Restem, LLC.Industry (pharma, biotech, devices)
Study start: 23 Dec 2020 (actual)
Primary completion: 12 May 2023 (actual)
Study completion: 12 May 2023 (actual)
First posted: 31 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
ULSC in Phase 1 Open Label	Experimental	Biological: Umbilical Cord Lining Stem Cells (ULSC)Intravenous (IV) infusion of ULSC in 20 patients with COVID-19 ARDS: In Phase 1, two separate cohorts per group will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The first cohort enrolled will receive the single dose; the next cohort enrolled will be administered the repeat dose regimen.
ULSC in Phase 2a Randomized	Experimental	Biological: Umbilical Cord Lining Stem Cells (ULSC)Intravenous (IV) infusion of ULSC in 30 patients with COVID-19 ARDS: In Phase 2a, 30 patients assigned ULSC will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The ULSC dosing regimen will be chosen based on Phase 1 data of safety and tolerability.
Placebo in Phase 2a Randomized	Placebo comparator	Other: Placebo (carrier control)Intravenous (IV) infusion of carrier control in 10 patients with COVID-19 ARDS: In Phase 2a, 10 patients assigned Placebo will receive either single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval) of carrier control; the dosing regimen will correspond to that of the experimental arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Adult, male or female, age ≥18 years old
Diagnosis of the presence of the COVID-19 agent with confirmation of COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent test.
Patient with diagnosis of COVID-related ARDS, classified as either:
According to Berlin Definition of Acute Respiratory Distress Syndrome (ARDS), patients will be categorized based on degrees of hypoxemia [arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2)]:
Patient who has exhibited deterioration in condition during the past 72 hours prior to the informed consent.

Key exclusion criteria (6 listed)

Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).
Active cancer or prior diagnosis of cancer within the past year; however, patients with basal and squamous cell cancer of skin will not be excluded.
Organ transplant recipient.
Chronic renal failure being treated by renal replacement therapy (dialysis) before development of COVID-19.
Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up.

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
Umbilical Cord Lining Stem Cells (ULSC)Also: Umbilical Cord Lining Stem Cells (ULSC), type of mesenchymal stem cells (MSC) derived from single donor umbilical cord tissue for allogeneic useIV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection	Biological	ULSC in Phase 1 Open Label, ULSC in Phase 2a Randomized
Placebo (carrier control)IV infusion of carrier control consisting of sterile saline for injection	Other	Placebo in Phase 2a Randomized

Primary outcome

Incidence of Dose Limiting Toxicity (DLT)
Time frame: 24 hours
Number of subjects with a DLT event during or within 24 hours after ULSC infusion [Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Time frame: 1 week
Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Time frame: 1 month
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up

10 secondary outcomes

Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Time frame: 1 month
Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio
Time frame: 1 month
Number of ventilator-free days (VFD)
Time frame: 1 month
Changes in Complete Blood Count (CBC) with differential from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood glucose (mg/dL) from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of sodium (mEq/L) from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of potassium (mEq/L) from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of alanine transaminase (ALT; U/L) from baseline
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Change in Urinalysis (UA) from baseline
Time frame: 1 month

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 9 Apr 2024.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 Umbilical Cord Lining Stem Cells (ULSC) in people with Covid19 and Corona Virus Infection, run by Restem, LLC. at 2 sites 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 12 inclusion and 6 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

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?

Incidence of Dose Limiting Toxicity (DLT) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04494386.

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 9 Apr 2024.