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The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.
Conventional treatment modalities have not been able to provide complete and sustained resolution of symptoms following damage to the articular cartilage. Despite the numerous techniques available today, complete healing of damaged or defective cartilage or consistent reproduction of normal hyaline cartilage does not occur, and continuous drug administration or secondary surgeries are common.
Research in mesenchymal stem cells has had a rapid acceleration over the past decade and MSC-based therapy has become one of the objects of investigation for a new branch of medicine termed regenerative medicine. This emerging technology shows great promise for producing transplantable cartilage constructs to restore the function of degenerated joints.
CARTISTEM®, a combination of human umbilical cord blood-derived mesenchymal stem cells and sodium hyaluronate, is intended to be used as a single-dose cellular therapeutic agent for cartilage regeneration in human subjects with cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARTISTEM® | Experimental | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARTISTEM® | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| IKDC Score | Subjects underwent a self-assessment of knee function using the IKDC (International Knee Documentation Committee Assessment)subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Months 12 after IP administration in an exploratory fashion. The IKDC score from the Month 12 visit was used as a primary indicator of the post operative change. The outcome was presented with the post-operative change amount from the baseline. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Subjects underwent a self-assessment of joint pain using the 100-mm VAS (Visual Analogue Scale) before and at Months 12 and 24 after IP (investigational product) administration. Higher values represent worse joint pain. Use of NSAIDs and any other analgesics had to be discontinued for 48 hours and 24 hours, respectively, prior to the 100 mm VAS evaluation. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline. 100-mm VAS scores range from 0 to 100. Higher values represent worse joint pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J Cole, MD | Cartilage Restoration Center, Rush University Medical Center | Principal Investigator |
| Andreas H Gomoll, MD | Cartilage Repair Center, Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cartilage Restoration Center; RUSH University Medical Center | Chicago | Illinois | 60612 | United States | ||
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| Label | URL |
|---|---|
| Study to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose A Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: 2 to 5 cm2 (Dose A) CARTISTEM® |
| FG001 | Dose B Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: above 5 cm2 (Dose B) CARTISTEM® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose A Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: 2 to 5 cm2 (Dose A) CARTISTEM® |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IKDC Score | Subjects underwent a self-assessment of knee function using the IKDC (International Knee Documentation Committee Assessment)subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Months 12 after IP administration in an exploratory fashion. The IKDC score from the Month 12 visit was used as a primary indicator of the post operative change. The outcome was presented with the post-operative change amount from the baseline. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
24 months
General safety was evaluated via the following assessments: adverse events (AEs), routine clinical laboratory tests (hematology, clinical chemistry, and urinalysis), thrombin generation (prothrombin time and activated partial thromboplastin time [aPTT]), immunogenicity tests (T cell subset), vital signs, physical examinations, and magnetic resonance imaging (MRI) for tumorigenicity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose A Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: 2 to 5 cm2 (Dose A) CARTISTEM® |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| JOINT RANGE OF MOTION DECREASED | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Product Development Department | MEDIPOST Co., Ltd. | +82-2-3465-6740 | meehyunj@medi-post.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2017 | May 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 24 months |
| Lysholm Score | The Lysholm knee scoring scale is a self-assessment that rates the severity of common complaints related to knee problems, such as pain, swelling, abnormal sensations, and ability to squat or climb stairs. The possible score ranges from 0 to 100, where 100 = no symptoms or disability. Scores are categorized as excellent (95 to 100), good (84 to 94), fair (65 to 83), and poor (≤64). Subjects underwent a self-assessment of knee function using the Lysholm score before IP administration and at Months 12 and 24 after IP administration. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline. | 24 months |
| KOOS Score | The Knee Injury and Osteoarthritis Outcome score (KOOS) knee survey is a self assessment of knee function and knee-related quality of life (QOL). Subjects responded to each question regarding knee-related symptoms, swelling, pain, impaired function, or changes in QOL with 1 of 5 possible answers that range from "never/not at all" to "always/extremely." The possible score for each parameter ranges from 0 to 100, where 0=extreme problems and 100=no problems. Subjects completed the KOOS knee survey before IP (investigational product) administration and at Month 24 after IP administration. The outcome was presented with the post-operative change amount at Month 24 from the baseline. | 24 months |
| IKDC Score | Subjects underwent a self-assessment of knee function using the IKDC subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Month 24 after IP administration in an exploratory fashion. The outcome was presented with the post-operative change amount at Month 24 from the baseline. | 24 months |
| Cartilage Repair Center; Brigham and Women's Hospital |
| Chestnut Hill |
| Massachusetts |
| 02467 |
| United States |
| Dose B Cohort |
Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: above 5 cm2 (Dose B) CARTISTEM® |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Dose B Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: above 5 cm2 (Dose B) CARTISTEM® |
|
|
| Secondary | VAS | Subjects underwent a self-assessment of joint pain using the 100-mm VAS (Visual Analogue Scale) before and at Months 12 and 24 after IP (investigational product) administration. Higher values represent worse joint pain. Use of NSAIDs and any other analgesics had to be discontinued for 48 hours and 24 hours, respectively, prior to the 100 mm VAS evaluation. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline. 100-mm VAS scores range from 0 to 100. Higher values represent worse joint pain. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Lysholm Score | The Lysholm knee scoring scale is a self-assessment that rates the severity of common complaints related to knee problems, such as pain, swelling, abnormal sensations, and ability to squat or climb stairs. The possible score ranges from 0 to 100, where 100 = no symptoms or disability. Scores are categorized as excellent (95 to 100), good (84 to 94), fair (65 to 83), and poor (≤64). Subjects underwent a self-assessment of knee function using the Lysholm score before IP administration and at Months 12 and 24 after IP administration. The outcome was presented with the post-operative change amount at Months 12 and 24 from the baseline. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | KOOS Score | The Knee Injury and Osteoarthritis Outcome score (KOOS) knee survey is a self assessment of knee function and knee-related quality of life (QOL). Subjects responded to each question regarding knee-related symptoms, swelling, pain, impaired function, or changes in QOL with 1 of 5 possible answers that range from "never/not at all" to "always/extremely." The possible score for each parameter ranges from 0 to 100, where 0=extreme problems and 100=no problems. Subjects completed the KOOS knee survey before IP (investigational product) administration and at Month 24 after IP administration. The outcome was presented with the post-operative change amount at Month 24 from the baseline. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | IKDC Score | Subjects underwent a self-assessment of knee function using the IKDC subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Month 24 after IP administration in an exploratory fashion. The outcome was presented with the post-operative change amount at Month 24 from the baseline. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Dose B Cohort | Drug name and ingredients: CARTISTEM [allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate] Dosage: Administer 0.5 mL of the combination product per cm^2 of the cartilage defect Cartilage defect size range: above 5 cm2 (Dose B) CARTISTEM® | 0 | 6 | 0 | 6 | 6 | 6 |
| bone marrow oedema | Blood and lymphatic system disorders | Systematic Assessment |
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| sinusitis | Infections and infestations | Systematic Assessment |
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| procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| soft tissue injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| blood pressure increased | Investigations | Systematic Assessment |
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| nuclear magnetic resonance imaging abnormal | Investigations | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| muscle atrophy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| joint crepitation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| chondromalacia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| chondropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| exostosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| haemarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| joint lock | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| plica syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| prehypertension | Vascular disorders | Systematic Assessment |
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| QOL (24 MONTHS) |
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| SPORTS (24 MONTHS) |
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| SYMPTOM (24 MONTHS) |
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