Long COVID-19Phase 2NCT05719012
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19
A Phase 2 study testing UC-MSCs in people with Long COVID-19, run by Shanghai East Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long COVID-19
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Mar 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age ranges from 18 to 85 (inclusive), regardless of gender.
- Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
- Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.
- Be expected to live longer than 1 year.
- Volunteer to participate in this clinical study and sign the written informed consent.
Who cannot join
- Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
- T lymphocyte abnormality, HIV positive.
- Highly allergic or have a history of severe allergy.
- Pregnant and lactating women.
- Patients with severe autoimmune disease history;
- Patients with uncontrolled chronic diseases or serious complications;
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- Patients with malignant tumors;
- Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;
- Patients with severe organ dysfunction
- Other situations that the researchers think are not suitable for participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19
- Conditions
- Long COVID-19
- Being tested
- UC-MSCs
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
Intravenous injection three times with one-month interval
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs | Experimental | UC-MSCs Receives: Biological: UC-MSCs |
| Placebo | Placebo comparator | 0.9% Normal Saline Receives: Biological: UC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six min walking distances
The maximum distance a person can walk in 6 min and acts as an endurance walking measure.
Measured: Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
Lung function
The lung function assessed using FEV1, FEV1/FVC and DLco
Measured: Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
Secondary outcomes (2)
Changes of the levels of Inflammatory cytokines
The levels of Inflammatory cytokines
Measured: Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
Changes of the scores of Multidimensional Fatigue Inventory
The degree of fatigue
Measured: Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Why it stopped: Difficulty in Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719012
- Sponsor's protocol ID
- DFSC-2023(CR)-02
- Status last verified
- Nov 2023
- First submitted
- 29 Jan 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study
- ClinicalTrials.gov ID
- NCT05719012
- Acronym / sponsor ID
- DFSC-2023(CR)-02
- Conditions
- Long COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs | Experimental | Biological: UC-MSCsUC-MSCs |
| Placebo | Placebo comparator | Biological: UC-MSCs0.9% Normal Saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age ranges from 18 to 85 (inclusive), regardless of gender.
- Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
- Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.
- Be expected to live longer than 1 year.
- Volunteer to participate in this clinical study and sign the written informed consent.
Key exclusion criteria (10 listed)
- Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
- T lymphocyte abnormality, HIV positive.
- Highly allergic or have a history of severe allergy.
- Pregnant and lactating women.
- Patients with severe autoimmune disease history;
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 |
|---|---|---|
| UC-MSCsIntravenous injection three times with one-month interval | Biological | Placebo, UC-MSCs |
Primary outcome
Six min walking distances
Time frame: Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
The maximum distance a person can walk in 6 min and acts as an endurance walking measure.
Lung function
Time frame: Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
The lung function assessed using FEV1, FEV1/FVC and DLco
2 secondary outcomes
Changes of the levels of Inflammatory cytokines
Time frame: Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
Changes of the scores of Multidimensional Fatigue Inventory
Time frame: Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UC-MSCs in people with Long COVID-19, run by Shanghai East Hospital at 1 site in China.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Nov 2023. 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 China. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Six min walking distances (time frame: Changes from baseline index at Day 30, Day 60, Day 90 and Day 180). 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 21 Nov 2023.