ClinicalTrials.gg
RecruitingNCT07754175Updated Aug 10, 2026

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial

An observational study in Knee Osteoarthritis, sponsored by Kang Stem Biotech Co., Ltd.. Recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

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

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
36
Ages
19 Years and older
Sex
All
01

Where this study stands

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

Among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of — 13 open to participants now, 21 under way, 4 of them phase 3. Osteoarthritis, Knee · Korea, Republic of.

Planned enrollment
9th of 11
36 · median 50
Started
2026
with 4 others
Observational
11 of 96
4 open now
Primary completion
2031-12
later than 20 of 20 live
Registered
92nd of 96
by date

Among the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, this one is the 9th largest by planned enrollment of the 11 observational ones that give a count, is one of 5 that started in 2026, is one of 11 observational ones, reaches primary completion later than 20 of the 20 other live ones, and was the 92nd registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

13 of the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 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 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 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.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, or all of them as a file.
02

Study summary

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial

03

Conditions studied

  • Knee Osteoarthritis

Keywords

  • FURESTEM-OA Kit Inj.
  • Knee Osteoarthritis Stem cell
04

Who can participate

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

Study population

Participants who received placebo in the K0701 clinical trial, completed the long-term follow-up study, and voluntarily provided written informed consent to participate in this extension 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

  • Participants who received placebo in the K0701 clinical trial and completed the Long-term follow-up study
  • Participants who voluntarily provide written to participate in this extension study

Exclusion criteria

Exclusion Criteria:

Participants meeting any of the following criteria:

  • Participants whom the investigator considers unsuitable for participation in this extension study.
  • Pregnant or breastfeeding women, and women of or men who do not agree to use an appropriate method of during the study
Terms in these criteria, in plain language(3)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Event, AESI(Adverse Event of Special Interest)

    Time frame: 5 years follow-up after treatment

Secondary outcomes

  1. Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  2. Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  3. Changes in 100-mm VAS

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  4. Changes in International Knee Documentation Committee Scoring System (IKDC)

    Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  5. Evaluation of International K&L grade(X-ray)

    Time frame: Month 12, Month 24 after treatment

  6. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)

    Time frame: Month 12, Month 24 after treatment

  7. Whole-Organ Magnetic Resonance Imaging Score (WORMS) score

    Time frame: Month 12, Month 24 after treatment

07

Study locations

1 of 2 sites recruiting
  • CHA University Bundang Medical Center
    Seoul, South Korea
    Recruiting
    • Jae Young Park, professor · Contact
  • Kyung Hee University Hospital
    Seoul, South Korea
    Not yet recruiting
    • Kyoung Ho Yoon Yoon, professor · Principal investigator
08

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

Started Jul 2026 (actual). Primary completion is estimated for Dec 2031, 65 months after the start.

Of 220 observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 61. This study's planned 65 months is above that.

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

Registered
Aug 4, 2026
First posted
Aug 10, 2026
StartActual
Jul 20, 2026
Primary completionEst.
Dec 31, 2031
CompletionEst.
Feb 28, 2032
Last update
Aug 10, 2026
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 Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07754175
Lead sponsor
Kang Stem Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Jul 20, 2026
Primary completion
Dec 31, 2031 (estimated)
Completion
Feb 28, 2032 (estimated)
Last update
Aug 10, 2026

Study contacts

Moonkyoung Kim
Contact
mkkim@kangstem.com
02-2036-7526
Yeonsil Yu
Contact
yuys@kangstem.com
02-2036-7571
Kyoung Ho Yoon, professor (CI)
principal investigator · Kyung Hee University Hospital
Sang Hak Lee, professor
principal investigator · Gangdong Kyunghee University Hospital
Jang Ki Mo, professor
principal investigator · Korea University Anam Hospital
Sang Gyun Kim, professor
principal investigator · National medical center
Seok jung Kim, professor
principal investigator · The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Jae Young Park, professor
principal investigator · CHA University Bundang Medical Center
Sung Hwan Kim, professor
principal investigator · Severance Hospital, Yonsei University College of Medicine

Oversight

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

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