Articular Cartilage Disorder of KneePhase 2NCT03101163
Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee
A Phase 2 study testing Autologous peripheral blood stem cells and hyaluronic acid and Hyaluronic acid in people with Articular Cartilage Disorder of Knee and Articular Cartilage; Degeneration, run by KLSMC Stem Cells, Inc. at 2 sites in 2 countries.
Trial summary
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Articular Cartilage Disorder of Knee, Articular Cartilage; Degeneration
- What is being tested?
- Autologous peripheral blood stem cells and hyaluronic acid and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2015to Jul 2022
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 to 55 years at screening (20 to 57 years for the open-label extension)
- Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions
- Provide written informed consent
- International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee
- All subjects must also satisfy at least 1 of the following inclusion criteria:
- Isolated knee articular cartilage lesion (single lesion) estimated to be ≥3 cm2 as demonstrated on MRI scanning. Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be ≥3 cm2 as demonstrated on MRI scanning. Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be ≥3 cm2. One or more cartilage defects involving the patello-femoral joint as demonstrated on MRI scanning with at least 1 lesion ≥3 cm2. One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion to be ≥3 cm2. Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI)
Who cannot join
- Three or more previous surgical interventions on the knee in question.
- Preoperative flexion deformity greater than 10 degrees.
- Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Andrews Research & Education Foundation (AREF)
Gulf Breeze, Florida, 32561
About this study
Official title: Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
Read the detailed description
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
- Being tested
- Autologous peripheral blood stem cells and hyaluronic acid, Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral blood stem cells and hyaluronic acidBiological
Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
Hyaluronic acidOther
Regimen of intra-articular HA injections and postoperative physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects randomized to the intervention group will undergo subchondral drilling surgery according to standard protocol, and will also receive a regimen of PBSC and HA intra-articular injections and postoperative physiotherapy. Receives: Biological: Autologous peripheral blood stem cells and hyaluronic acid |
| Standard treatment | Active comparator | Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen. Receives: Other: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) score
Subjective IKDC core as a measure of joint function
Measured: 24 months
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
KOOS pain subdomain score as a measure of joint pain
Measured: 24 months
Secondary outcomes (1)
Numeric Rating Scale (NRS) for pain
Numeric Rating Scale (NRS) for pain
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startDec 2015
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Disorder of 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLSMC Stem Cells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101163
- Sponsor's protocol ID
- KLSMC-003
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group
- ClinicalTrials.gov ID
- NCT03101163
- Acronym / sponsor ID
- KLSMC-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KLSMC Stem Cells, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 4 Apr 2017 (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.
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
Detailed description
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Autologous peripheral blood stem cells and hyaluronic acidSubjects randomized to the intervention group will undergo subchondral drilling surgery according to standard protocol, and will also receive a regimen of PBSC and HA intra-articular injections and postoperative physiotherapy. |
| Standard treatment | Active comparator | Other: Hyaluronic acidSubjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 to 55 years at screening (20 to 57 years for the open-label extension)
- Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions
- Provide written informed consent
- International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee
- All subjects must also satisfy at least 1 of the following inclusion criteria:
Key exclusion criteria (3 listed)
- Three or more previous surgical interventions on the knee in question.
- Preoperative flexion deformity greater than 10 degrees.
- Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration
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 |
|---|---|---|
| Autologous peripheral blood stem cells and hyaluronic acidRegimen of intra-articular PBSC and HA injections and postoperative physiotherapy | Biological | Intervention |
| Hyaluronic acidRegimen of intra-articular HA injections and postoperative physiotherapy | Other | Standard treatment |
Primary outcome
International Knee Documentation Committee (IKDC) score
Time frame: 24 months
Subjective IKDC core as a measure of joint function
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
Time frame: 24 months
KOOS pain subdomain score as a measure of joint pain
1 secondary outcome
Numeric Rating Scale (NRS) for pain
Time frame: 24 months
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 16 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous peripheral blood stem cells and hyaluronic acid and Hyaluronic acid in people with Articular Cartilage Disorder of Knee and Articular Cartilage; Degeneration, run by KLSMC Stem Cells, Inc. at 2 sites in 2 countries.
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 6 inclusion and 3 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Malaysia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
International Knee Documentation Committee (IKDC) score (time frame: 24 months). The study lists 2 primary outcomes in all. 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 16 Aug 2022.