Long COVIDPhase 2NCT05682560
Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
A Phase 2 study testing REGENECYTE in people with Long COVID and Post-COVID Syndrome, run by StemCyte, Inc. at 1 site in United States.
Trial summary
REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID, Post-COVID Syndrome, Post COVID-19 Condition
- What is being tested?
- REGENECYTE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 27 Feb 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female aged ≥ 18
- 2. With post-COVID syndrome
- 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
- 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
- 5. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent
Who cannot join
- 1. Neurological disorders prior to COVID-19 diagnosis
- 2. With pre-existing terminal illness
- 3. With known immune disease
- 4. Is pregnant or breastfeeding
- 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
- 6. Has received any vaccination within 3 weeks prior to the first IP infusion
- 7. Judged by the investigator to be not suitable for study participation
- 8. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.
Read the detailed description
This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.
- Conditions
- Long COVID, Post-COVID Syndrome, Post COVID-19 Condition
- Being tested
- REGENECYTE, Placebo
- Keywords
- Long COVID, Post-COVID Syndrome, Post-COVID condition, Umbilical cord blood, RegeneCyte
- 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.
REGENECYTEBiological
HPC, Cord Blood
PlaceboBiological
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| REGENECYTE | Experimental | HPC, Cord Blood Receives: Biological: REGENECYTE |
| Placebo | Placebo comparator | Normal Saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Baseline to Week 26
Secondary outcomes (1)
Change of fatigue score as measured by CFQ-11
Measured: Baseline, Week 6, 12, 18 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start4 May 2023
- Primary completion26 Jul 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- StemCyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- StemCyte Taiwan Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682560
- Sponsor's protocol ID
- SCUS001
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All information supplied by StemCyte, Inc in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, clinical protocol, case report forms and other scientific data. All data collected during the study are confidential. This confidential information shall remain the sole property of StemCyte, Inc, shall not be disclosed to others without the written consent of StemCyte, Inc, and shall not be used except in the performance of this study.
Publications
Huang YW, Chen YC, Lun Lau EY, Su YC, Tai LK, Rosenthal J, Wang J, Lee TY. REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial. EClinicalMedicine. 2026 Jan 9;91:103737. doi: 10.1016/j.eclinm.2025.103737. eCollection 2026 Jan.
PubMed 41625963
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
- ClinicalTrials.gov ID
- NCT05682560
- Acronym / sponsor ID
- SCUS001
- Conditions
- Long COVID, Post-COVID Syndrome, Post COVID-19 Condition
- Keywords
- Long COVID, Post-COVID Syndrome, Post-COVID condition, Umbilical cord blood, RegeneCyte
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- StemCyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- StemCyte Taiwan Co., Ltd.
- Study start
- 4 May 2023 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 12 Jan 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.
REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.
Detailed description
This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGENECYTE | Experimental | Biological: REGENECYTEHPC, Cord Blood |
| Placebo | Placebo comparator | Biological: PlaceboNormal Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male or female aged ≥ 18
- 2. With post-COVID syndrome
- 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
- 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
- 5. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent
Key exclusion criteria (8 listed)
- 1. Neurological disorders prior to COVID-19 diagnosis
- 2. With pre-existing terminal illness
- 3. With known immune disease
- 4. Is pregnant or breastfeeding
- 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
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 |
|---|---|---|
| REGENECYTEHPC, Cord Blood | Biological | REGENECYTE |
| PlaceboNormal Saline | Biological | Placebo |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Week 26
Incidence of treatment-emergent adverse events (TEAEs)
1 secondary outcome
Change of fatigue score as measured by CFQ-11
Time frame: Baseline, Week 6, 12, 18 and 26
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 24 Mar 2025.
- Derived from this study: PubMed 41625963Huang YW, Chen YC, Lun Lau EY, Su YC, Tai LK, Rosenthal J, Wang J, Lee TY. REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial. EClinicalMedicine. 2026 Jan 9;91:103737. doi: 10.1016/j.eclinm.2025.103737. eCollection 2026 Jan.
- Individual participant dataSharing planned: Undecided. All information supplied by StemCyte, Inc in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, clinical protocol, case report forms and other scientific data. All data collected during the study are confidential. This confidential information shall remain the sole property of StemCyte, Inc, shall not be disclosed to others without the written consent of StemCyte, Inc, and shall not be used except in the performance of this study.
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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 REGENECYTE in people with Long COVID and Post-COVID Syndrome, run by StemCyte, Inc. 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 5 inclusion and 8 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 24 Mar 2025. 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 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?
Treatment-emergent adverse events (TEAEs) (time frame: Baseline to Week 26). 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 NCT05682560, which also lists 1 linked publication.
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 24 Mar 2025.