Long COVIDPhase 3NCT07184385
A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition
A Phase 3 study testing REGENECYTE in people with Long COVID and Post-COVID-19 Condition, run by StemCyte, Inc..
Trial summary
REGENECYTE (HPC, Cord Blood) 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-19 Condition, Post-COVID Syndrome
- What is being tested?
- REGENECYTE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female aged ≥ 18
- With post-COVID condition
- Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
- Able to provide signed informed consent (by the subject or his/her legally authorized representative)
- 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
- Neurological disorders prior to COVID-19 diagnosis
- With pre-existing terminal illness
- With known immune disease
- Is pregnant or breastfeeding
- Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
- Has received any vaccination within 3 weeks prior to the first IP infusion or planning to receive vaccination during the treatment period
- Judged by the investigator to be not suitable for study participation, including but not limited to pre-existing chronic diseases
- Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.
Read the detailed description
This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.
- Being tested
- REGENECYTE, Placebo
- Keywords
- Post-COVID condition, Post-COVID syndrome, Long COVID, REGENECYTE, Post-COVID fatigue, Umbilical cord blood
- 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.
The change of efficacy
Change of efficacy evaluation
Measured: Week
Secondary outcomes (1)
Treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start31 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StemCyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184385
- Sponsor's protocol ID
- SCUS002
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
- ClinicalTrials.gov ID
- NCT07184385
- Acronym / sponsor ID
- SCUS002
- Keywords
- Post-COVID condition, Post-COVID syndrome, Long COVID, REGENECYTE, Post-COVID fatigue, Umbilical cord blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- StemCyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Sep 2025 (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) for treatment in patients with post-COVID.
Detailed description
This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- 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)
- Male or female aged ≥ 18
- With post-COVID condition
- Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
- Able to provide signed informed consent (by the subject or his/her legally authorized representative)
- 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)
- Neurological disorders prior to COVID-19 diagnosis
- With pre-existing terminal illness
- With known immune disease
- Is pregnant or breastfeeding
- 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
The change of efficacy
Time frame: Week
Change of efficacy evaluation
1 secondary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REGENECYTE in people with Long COVID and Post-COVID-19 Condition, run by StemCyte, Inc..
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: opening soon, as of the sponsor's last update on 23 Sep 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernest Lau, MS (886-2-26013013 ext. 813, Sct_pCOV02@stemcyte.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of efficacy (time frame: Week). 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 23 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.