Back to resultsEfficacy 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
Primary Purpose
Articular Cartilage Disorder of Knee, Articular Cartilage; Degeneration
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Autologous peripheral blood stem cells and hyaluronic acid
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Disorder of Knee
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Andrews Research & Education Foundation (AREF)
- Kuala Lumpur Sports Medicine Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Standard treatment
Arm Description
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.
Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.
Outcomes
Primary Outcome Measures
International Knee Documentation Committee (IKDC) score
Subjective IKDC core as a measure of joint function
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
KOOS pain subdomain score as a measure of joint pain
Secondary Outcome Measures
Numeric Rating Scale (NRS) for pain
Numeric Rating Scale (NRS) for pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03101163
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KLSMC Stem Cells, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder of Knee, Articular Cartilage; Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.
Intervention Type
Biological
Intervention Name(s)
Autologous peripheral blood stem cells and hyaluronic acid
Intervention Description
Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid
Intervention Description
Regimen of intra-articular HA injections and postoperative physiotherapy
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) score
Description
Subjective IKDC core as a measure of joint function
Time Frame
24 months
Title
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
Description
KOOS pain subdomain score as a measure of joint pain
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) for pain
Description
Numeric Rating Scale (NRS) for pain
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Andrews Research & Education Foundation (AREF)
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Kuala Lumpur Sports Medicine Centre
City
Kuala Lumpur
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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