Deficiency of Anterior Cruciate LigamentNCT02755376
Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell
A study testing Cartistem(TM), hyaluronic acid and ACL reconstruction only in people with Deficiency of Anterior Cruciate Ligament, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Deficiency of Anterior Cruciate Ligament
- What is being tested?
- Cartistem(TM), hyaluronic acid and ACL reconstruction only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2014to 1 Dec 2018
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20~50
- Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
- prothrombin time (PT) (INR) <1.5, activated partial thromboplastin time (aPTT) <1.5 x control
- Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
- Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
- No surgery and radiation therapy in recent 6 weeks
Show all 9Show fewer
- No pregnancy
- No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0~5mm, grade II: 5~10mm, grade III: >10mm)
- voluntary singed a consent form
Who cannot join
- Degenerative osteoarthritis in knee
- Revision or other surgery history (stem cell treatment)
- Chronic inflammatory joint disease like rheumatoid arthritis
- Infectious disease need to administration of parenteral antibiotics
- Autoimmune disease
- Myocardial infarction, congestive heart failure, other serious heart disease
Show all 18Show fewer
- Uncontrolled hypertension
- Serious medical disease
- Pregnancy and breast-feeding
- psychiatric disorder and epilepsy
- Alcohol overuse
- Smoking overuse
- Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
- Patient participating in other clinical trials in recent 4 weeks
- Combined ligament instability ≥ grade II in physical test.
- No allergy history to gentamicin antibiotics
- Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent
- Inappropriate patient judged by researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Center, Investigator Initiated Clinical Trial to Evaluate Enhancement of Healing Between Bone Tunnel and Graft in Anterior Cruciate Ligament (ACL) Injury Using Human Umbilical Cord Blood Derived Mesenchymal Stem Cell
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Read the detailed description
- Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
- Subject: Anterior cruciate ligament (ACL) injury 30 patients
- ACL reconstruction: 10
- ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10
- ACL reconstruction + hyaluronic acid: 10
- Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
- Conditions
- Deficiency of Anterior Cruciate Ligament
- Being tested
- Cartistem(TM), hyaluronic acid, ACL reconstruction only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartistem(TM)Biological
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
hyaluronic acidBiological
ACL reconstruction and injection of hyaluronic acid under arthroscopy.
ACL reconstruction onlyProcedure or surgery
ACL reconstruction only without any injection under arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction only | Active comparator | only ACL reconstruction without any injection Receives: Procedure: ACL reconstruction only |
| ACL reconstruction + Cartistem(TM) | Experimental | ACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy. Receives: Biological: Cartistem(TM); Procedure: ACL reconstruction only |
| ACL reconstruction + Hyaluronic acid | Experimental | ACL reconstruction and concomitant hyaluronic acid injection under arthroscopy Receives: Biological: hyaluronic acid; Procedure: ACL reconstruction only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone formation on interface between bone tunnel and graft
Measured: Changes at 12 week, 24 week, 48 week after surgery
Secondary outcomes (6)
Arthroscopic grading of graft
Measured: 48 week after surgery
Telos stress X-ray
Measured: Changes at 12 week, 24 week, 48 week after surgery
KT-2000
Measured: Changes at 12 week, 24 week, 48 week after surgery
clinical knee scoring
Measured: Changes at 12 week, 24 week, 48 week after surgery
Instability assessing with physical examination
Measured: Changes at 12 week, 24 week, 48 week after surgery
Tunnel enlargement after anterior cruciate ligament reconstruction
Measured: Changes at 12 week, 24 week, 48 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start1 Jan 2014
- Primary completion28 Apr 2016
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joon Ho Wang, MD, Ph D, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755376
- Sponsor's protocol ID
- SMC 2013-07-117-002
- Status last verified
- Dec 2018
- First submitted
- 22 Feb 2015
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: age, physical exam, lab, etc will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Investigator Initiated Clinical Trial to Evaluate Enhancement of Healing Between Bone Tunnel and Graft in Anterior Cruciate Ligament (ACL) Injury Using Human Umbilical Cord Blood Derived Mesenchymal Stem Cell
- ClinicalTrials.gov ID
- NCT02755376
- Acronym / sponsor ID
- SMC 2013-07-117-002
- Conditions
- Deficiency of Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Detailed description
- Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
- Subject: Anterior cruciate ligament (ACL) injury 30 patients
- ACL reconstruction: 10
- ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10
- ACL reconstruction + hyaluronic acid: 10
- Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction only | Active comparator | Procedure: ACL reconstruction onlyonly ACL reconstruction without any injection |
| ACL reconstruction + Cartistem(TM) | Experimental | Biological: Cartistem(TM), Procedure: ACL reconstruction onlyACL reconstruction and concomitant Cartistem(TM) injection which is human cord blood derived mesenchymal stem cell under arthroscopy. |
| ACL reconstruction + Hyaluronic acid | Experimental | Biological: hyaluronic acid, Procedure: ACL reconstruction onlyACL reconstruction and concomitant hyaluronic acid injection under arthroscopy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 20~50
- Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
- prothrombin time (PT) (INR) <1.5, activated partial thromboplastin time (aPTT) <1.5 x control
- Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
- Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
Key exclusion criteria (18 listed)
- Degenerative osteoarthritis in knee
- Revision or other surgery history (stem cell treatment)
- Chronic inflammatory joint disease like rheumatoid arthritis
- Infectious disease need to administration of parenteral antibiotics
- Autoimmune disease
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 |
|---|---|---|
| Cartistem(TM)ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy. | Biological | ACL reconstruction + Cartistem(TM) |
| hyaluronic acidACL reconstruction and injection of hyaluronic acid under arthroscopy. | Biological | ACL reconstruction + Hyaluronic acid |
| ACL reconstruction onlyACL reconstruction only without any injection under arthroscopy | Procedure or surgery | ACL reconstruction + Cartistem(TM), ACL reconstruction + Hyaluronic acid, ACL reconstruction only |
Primary outcome
Bone formation on interface between bone tunnel and graft
Time frame: Changes at 12 week, 24 week, 48 week after surgery
6 secondary outcomes
Arthroscopic grading of graft
Time frame: 48 week after surgery
Telos stress X-ray
Time frame: Changes at 12 week, 24 week, 48 week after surgery
KT-2000
Time frame: Changes at 12 week, 24 week, 48 week after surgery
clinical knee scoring
Time frame: Changes at 12 week, 24 week, 48 week after surgery
Instability assessing with physical examination
Time frame: Changes at 12 week, 24 week, 48 week after surgery
Tunnel enlargement after anterior cruciate ligament reconstruction
Time frame: Changes at 12 week, 24 week, 48 week after surgery
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 10 Apr 2019.
- Individual participant dataSharing planned: Undecided. age, physical exam, lab, etc will be shared
Related trials for Deficiency of Anterior Cruciate Ligament
Not yet recruitingObservational study
AI-Based Video Assessment of Anterior Knee Laxity
ACL - Anterior Cruciate Ligament Deficiency
RecruitingObservational study
5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture
ACL - Anterior Cruciate Ligament Deficiency
RecruitingObservational study
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
ACL - Anterior Cruciate Ligament Deficiency
Not yet recruitingObservational study
Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
Anterior Cruciate Ligament (ACL) Tear
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.
Joon Ho Wang, MD, Ph D study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartistem(TM), hyaluronic acid and ACL reconstruction only in people with Deficiency of Anterior Cruciate Ligament, run by Samsung Medical Center at 1 site in South Korea.
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 9 inclusion and 18 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 10 Apr 2019. 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 South Korea. 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. 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?
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?
Bone formation on interface between bone tunnel and graft (time frame: Changes at 12 week, 24 week, 48 week after surgery). 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 10 Apr 2019.