Osteoarthritis, KneeNCT04234412
Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
A study testing umbilical cord blood stem cell implantation for osteoarthritis treatment in people with Osteoarthritis, Knee, run by Uijeongbu St. Mary Hospital.
Trial summary
The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- umbilical cord blood stem cell implantation for osteoarthritis treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Nov 2022
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 30 years,
- full-thickness cartilage lesion measuring at least 2 cm2,
- femoro-tibial angle (varus or valgus) 5°< in the mechanical axis
Who cannot join
- ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
- metabolic arthritis
- infectious condition
- psychosis
- serious medical illness
- pregnancy
About this study
The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint.
This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint.
Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.
- Conditions
- Osteoarthritis, Knee
- Being tested
- umbilical cord blood stem cell implantation for osteoarthritis treatment
- Keywords
- osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord blood stem cell implantation for osteoarthritis treatmentProcedure or surgery
The arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl.
Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritic knee patients | Experimental | Osteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells. Receives: Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Cartilage Repair Society (ICRS) grade improvement
over grade 1 should be improved
Measured: at 24, 48, 96 weeks after surgery, score changes will be observed.
Secondary outcomes (3)
Visual analogue scale (VAS)
0-10 score range, lower the better
Measured: at 24, 48, 96 weeks after surgery, score changes will be observed.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
0-100 score range, lower the better
Measured: at 24, 48, 96 weeks after surgery, score changes will be observed.
International Knee Documentation Committee (IKDC score)
0-100 % range, lower the better
Measured: at 24, 48, 96 weeks after surgery, score changes will be observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
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 Osteoarthritis, KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uijeongbu St. Mary Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seckjung Kim, Uijeongbu St. Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234412
- Sponsor's protocol ID
- UC19OISI0134
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: according to patient agreement, this is flexible.
Publications
Bae BS, Jung JW, Jo GO, Kim SA, Go EJ, Cho ML, Shetty AA, Kim SJ. Treatment of osteoarthritic knee with high tibial osteotomy and allogeneic human umbilical cord blood-derived mesenchymal stem cells combined with hyaluronate hydrogel composite. Stem Cell Res Ther. 2025 Apr 28;16(1):211. doi: 10.1186/s13287-025-04356-9.
PubMed 40296133
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
- ClinicalTrials.gov ID
- NCT04234412
- Acronym / sponsor ID
- UC19OISI0134
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, high tibial osteotomy, umbilical cord blood stem cell, cartilage regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Uijeongbu St. Mary HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 21 Jan 2020 (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.
The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint.
This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint.
Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritic knee patients | Experimental | Procedure: umbilical cord blood stem cell implantation for osteoarthritis treatmentOsteoarthritic Knee of the patients who will be treated wth high tibial osteotomy and implantation of allogenic human umbilical cord blood-derived stem cells. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age older than 30 years,
- full-thickness cartilage lesion measuring at least 2 cm2,
- femoro-tibial angle (varus or valgus) 5°< in the mechanical axis
Key exclusion criteria (6 listed)
- ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
- metabolic arthritis
- infectious condition
- psychosis
- serious medical illness
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 |
|---|---|---|
| umbilical cord blood stem cell implantation for osteoarthritis treatmentThe arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl. Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface. | Procedure or surgery | Osteoarthritic knee patients |
Primary outcome
International Cartilage Repair Society (ICRS) grade improvement
Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.
over grade 1 should be improved
3 secondary outcomes
Visual analogue scale (VAS)
Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.
International Knee Documentation Committee (IKDC score)
Time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 40296133Bae BS, Jung JW, Jo GO, Kim SA, Go EJ, Cho ML, Shetty AA, Kim SJ. Treatment of osteoarthritic knee with high tibial osteotomy and allogeneic human umbilical cord blood-derived mesenchymal stem cells combined with hyaluronate hydrogel composite. Stem Cell Res Ther. 2025 Apr 28;16(1):211. doi: 10.1186/s13287-025-04356-9.
- Individual participant dataSharing planned: Undecided. according to patient agreement, this is flexible.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord blood stem cell implantation for osteoarthritis treatment in people with Osteoarthritis, Knee, run by Uijeongbu St. Mary Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jan 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
International Cartilage Repair Society (ICRS) grade improvement (time frame: at 24, 48, 96 weeks after surgery, score changes will be observed.). 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 NCT04234412, 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 21 Jan 2020.