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COVID-19Phase 2NCT04428801

Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19

A Phase 2 study testing autologous adipose-derived stem cells in people with COVID-19, run by Celltex Therapeutics Corporation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
autologous adipose-derived stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
Sep 2023to Sep 2026
Phase
Phase 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

  • Age above 18 years.
  • Male or female
  • Subjects should have banked AdMSCs in Celltex (already passed communicable disease screen tests for HIV, syphilis, Hepatitis B and C during banking stage)
  • Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
  • Highly susceptible to SARS-Cov-2 infections, such as obesity (BMI ≥ 40), early to middle stage of hypertension (systolic pressure ranging above 140 Hg or a diastolic pressure ranging from 90 mm Hg), diabetic mellitus hemoglobin A1c >8%), chronic heart disease (one or more conditions including previously diagnosed as coronary artery disease, chronic heart arrhythmia, cardiomyopathy…) chronic pulmonary disease (COPD, fibrosis), chronic liver disease (Hepatic impairment, defined as any of ALT, AST, LDH or bilirubin > 2 x the upper limit of normal (ULN) range according to local laboratory standards) and kidney diseases (serum creatinine > 133 mmol/L (1.5 mg/dL). No terminal stages of the above medical conditions.
  • No previous COVID-19 history
  • SARS-CoV-2 RT-PCR or equivalent tests negative in respiratory tract specimen
  • Blood test for SARS-Cov-2 IgM and IgG negative

Who cannot join

  • Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
  • Unwillingness or inability to comply with study procedures
  • Blood test for SARS-Cov-2 antibodies IgM and IgG positive
  • Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
  • Clinically active malignant disease
  • Previous thrombotic disorder
Show all 19Show fewer
  • History of known pulmonary embolism or known secondary anti-phospholipid syndrome
  • Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
  • Major trauma or surgery within 14 days of study treatment start
  • Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
  • Alcohol, drug, or medication abuse within one year prior to study treatment start
  • Any condition in the Investigator's opinion that is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
  • Irreversible severe end-organ failures, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
  • Patients or family history with hypercoagulable states, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
  • History of long-term use of immunosuppressive agents
  • Organ transplant in the past 6 months
  • Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study
  • Patients with severe pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia. This includes patients with pulmonary imaging that reveals interstitial lung damage before contracting COVID-19.
  • QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.

Trial locations and contacts

No sites are listed yet.

Jane Young contact

7135901000

jyoung@celltexbank.com

About this study

Official title: Clinical Study for the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19)

This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.

Conditions
COVID-19
Being tested
autologous adipose-derived stem cells
Keywords
Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19 [NCT ID not yet assigned]
Medical subject headings
COVID-19

What participants receive

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

  • autologous adipose-derived stem cellsBiological

    Also called Celltex-AdMSCs

    Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Study groups in NCT04428801
Study groupRoleWhat they receive
Phase 2 AdMSC groupExperimentalEach subject receives three doses of 200 million autologous adipose derived mesenchymal stem cells via intravenously infusion every three days Other Names: Celltex-AdMSCs Celltex-AdMSCs
Receives: Biological: autologous adipose-derived stem cells
Phase 2 Placebo groupPlacebo comparatorThe control group- receive three doses of placebo via intravenously infusion every three days.
Receives: Biological: autologous adipose-derived stem cells

What is being measured

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

  1. Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication

    adverse events and severe adverse events

    Measured: 6 months

  2. The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group

    adverse events and severe adverse events

    Measured: 6 months

  3. COVID-19 incidence rates in both the study and control groups

    efficacy

    Measured: 6 months

Secondary outcomes (16)

  1. The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.

    efficacy

    Measured: 6 months

  2. The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.

    efficacy

    Measured: 6 months

  3. Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.

    efficacy

    Measured: 6 months

  4. Change of lymphocyte count in white blood cell counts from the baseline

    efficacy

    Measured: 6 months

  5. Change of PaO2 arterial blood gases from the baseline

    efficacy

    Measured: 6 months

  6. Compare the proportion of subjects who develop severe COVID-19 pneumonia cases for both study and control groups

    efficacy

    Measured: 6 months

  7. COVID-19 mortality rates for both study and control groups

    efficacy

    Measured: 6 months

  8. Change of C-reactive protein (CRP) (mg/L) from the baseline

    efficacy

    Measured: 6 months

  9. Change of D-dimer (mg/L) from the baseline

    efficacy

    Measured: 6 months

  10. Change of Procalcitonin (ug)/L from the baseline

    efficacy

    Measured: 6 months

  11. Change of pro-type B natriuretic peptide (pro-BNP) (pg/mL) from the baseline

    efficacy

    Measured: 6 months

  12. Change of Bilirubin (mg/dL) from the baseline

    efficacy

    Measured: 6 months

  13. Change of Creatinine (mg/dL) from the baseline

    efficacy

    Measured: 6 months

  14. Change in blood test values for cytokine panels (IL-1β, IL-6, IL-8, IL-10, TNFα) from the baseline

    efficacy

    Measured: 6 months

  15. The proportion of subjects from SARS-CoV-2 RT-PCR positive to negativity in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method. as compared to control group

    efficacy

    Measured: 6 months

  16. Quantifying viral RNA in stool for baseline and final follow-up.

    efficacy

    Measured: 6 months

Timeline

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

  1. First posted11 Jun 2020
  2. Study startSep 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Phase 2 study is a randomized, double-blind, placebo-control study conducted in multiple clinic facilities.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428801
Sponsor's protocol ID
CTX0020-003
Status last verified
Apr 2023
First submitted
8 Apr 2020
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing autologous adipose-derived stem cells in people with COVID-19, run by Celltex Therapeutics Corporation.

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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jane Young (7135901000, jyoung@celltexbank.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication (time frame: 6 months). The study lists 3 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 NCT04428801.

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 18 Apr 2023.

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