ClinicalTrials.gg
Not yet recruitingNCT04730024Updated Jan 29, 2021

Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj

An observational study in Atopic Dermatitis, sponsored by Kang Stem Biotech Co., Ltd.. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Kang Stem Biotech Co., Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
102
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 82 studies in Dermatitis, Atopic with a site in Korea, Republic of — 6 open to participants now, 17 under way, 6 of them phase 3. Dermatitis, Atopic · Korea, Republic of.

Planned enrollment
6th of 12
102 · median 101
Started
2022
with 4 others
Observational
12 of 82
3 open now
Primary completion
2030-06
later than 14 of 16 live
Registered
50th of 82
by date
Lead sponsor
9 of 82
Kang Stem Biotech Co., Ltd.

Among the 82 studies in Dermatitis, Atopic with a site in Korea, Republic of, this one is the 6th largest by planned enrollment of the 12 observational ones that give a count, is one of 5 that started in 2022, is one of 12 observational ones, reaches primary completion later than 14 of the 16 other live ones, and was the 50th registered.

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

Browse Dermatitis, Atopic studies →

Open to participants now

6 of the 82 studies in Dermatitis, Atopic with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 82 studies in Dermatitis, Atopic with a site in Korea, Republic of, or all of them as a file.
02

Study summary

A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study

03

Conditions studied

  • Atopic Dermatitis

Browse trials for

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject who enrolled K0104 Clinical Trial(parent study).
  2. Subjects who understand and voluntarily sign an form

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
  2. Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
  3. Subjects who are judged to be unsuitable for other researchers to participate in the research
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
102 participants (estimated)
Patient registry
No

Interventions

  • OtherNot applicable(observational study)

    Not applicable(observational study)

06

What researchers measure

Primary outcomes

  1. Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)

    Time frame: for 5 years

Secondary outcomes

  1. Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)

    Time frame: for 5 years

  2. Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)

    Time frame: for 5 years

  3. Rate of change and Change in EASI from baseline

    EASI range is from 0 (clear) to 72 (severe)

    Time frame: for 5 years

  4. Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1

    Time frame: for 5 years

  5. Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher

    Time frame: for 5 years

  6. Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)

    Time frame: for 5 years

  7. Rate of change and Change in SCORAD index from baseline at each visit

    SCORAD index range is from 0 (clear) to 103 (severe)

    Time frame: for 5 years

  8. Change and rate of change in Body Surface Area (BSA)

    Time frame: for 5 years

  9. Change and rate of change in total serum Immunoglobulin E (IgE)

    Time frame: for 5 years

  10. Change and rate of change DLQI

    Time frame: for 5 years

  11. Change and rate of change POEM

    Time frame: for 5 years

  12. Change and rate of change Peak Pruritus NRS

    Time frame: for 5 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2022; primary completion for Jun 2030, 99 months later.

Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 99 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2021
First posted
Jan 29, 2021
StartEst.
Mar 27, 2022
Primary completionEst.
Jun 30, 2030
CompletionEst.
Jun 30, 2030
Last update
Jan 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04730024
Lead sponsor
Kang Stem Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Jan 29, 2021
Start date
Mar 27, 2022 (estimated)
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jan 29, 2021

Study contacts

Eundoek Yeo
Contact
edyeo@kangstem.com
82-2-888-1592
Seulbi Lee
Contact
sblee@kangstem.com
82-2-888-1592

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion