Trial Outcomes & Findings for Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects (NCT NCT01733186)

Last Updated: 2026-01-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

12 months

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	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®	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®
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®	Total n=12 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 8.2 • n=35 Participants	39.7 years STANDARD_DEVIATION 8.0 • n=4328 Participants	38.0 years STANDARD_DEVIATION 7.9 • n=8687 Participants
Sex: Female, Male Female	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Sex: Female, Male Male	5 Participants n=35 Participants	5 Participants n=4328 Participants	10 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=35 Participants	6 Participants n=4328 Participants	12 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Race (NIH/OMB) White	5 Participants n=35 Participants	5 Participants n=4328 Participants	10 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Region of Enrollment United States	6 participants n=35 Participants	6 participants n=4328 Participants	12 participants n=8687 Participants
Body mass index	28.6 kg/m^2 STANDARD_DEVIATION 4.1 • n=35 Participants	26.6 kg/m^2 STANDARD_DEVIATION 4.5 • n=4328 Participants	27.6 kg/m^2 STANDARD_DEVIATION 4.3 • n=8687 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®
IKDC Score	32.0 score on a scale Standard Deviation 27.7	25.5 score on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®
VAS 24 MONTHS	-31.7 score on a scale Standard Deviation 18.0	-11.3 score on a scale Standard Deviation 30.2
VAS 12 MONTHS	-23.8 score on a scale Standard Deviation 22.9	-12.5 score on a scale Standard Deviation 31.5

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®
Lysholm Score 12 MONTHS	26.7 score on a scale Standard Deviation 20.5	22.5 score on a scale Standard Deviation 18.3
Lysholm Score 24 MONTHS	32.0 score on a scale Standard Deviation 20.9	10.2 score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®
KOOS Score ADL (24 MONTHS)	28.2 score on a scale Standard Deviation 25.7	12.3 score on a scale Standard Deviation 19.2
KOOS Score PAIN (24 MONTHS)	23.6 score on a scale Standard Deviation 24.3	15.8 score on a scale Standard Deviation 13.1
KOOS Score QOL (24 MONTHS)	50.0 score on a scale Standard Deviation 36.4	19.8 score on a scale Standard Deviation 24.2
KOOS Score SPORTS (24 MONTHS)	39.2 score on a scale Standard Deviation 37.2	36.7 score on a scale Standard Deviation 31.9
KOOS Score SYMPTOM (24 MONTHS)	24.4 score on a scale Standard Deviation 19.9	8.3 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure	Dose A Cohort n=6 Participants 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®	Dose B Cohort n=6 Participants 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®
IKDC Score	41.2 score on a scale Standard Deviation 25.8	27.5 score on a scale Standard Deviation 20.9

Adverse Events

Dose A Cohort

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose B Cohort

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director of Product Development Department

MEDIPOST Co., Ltd.

Phone: +82-2-3465-6740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose A Cohort n=6 participants at risk 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®	Dose B Cohort n=6 participants at risk 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®
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	100.0% 6/6 • Number of events 8 • 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.	100.0% 6/6 • Number of events 6 • 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.
Blood and lymphatic system disorders bone marrow oedema	16.7% 1/6 • Number of events 1 • 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.	33.3% 2/6 • Number of events 2 • 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.
Infections and infestations sinusitis	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Injury, poisoning and procedural complications procedural pain	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Injury, poisoning and procedural complications soft tissue injury	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Investigations blood creatine phosphokinase increased	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Investigations blood pressure increased	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Investigations nuclear magnetic resonance imaging abnormal	0.00% 0/6 • 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.	16.7% 1/6 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders arthralgia	83.3% 5/6 • Number of events 6 • 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.	100.0% 6/6 • Number of events 9 • 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.
Musculoskeletal and connective tissue disorders joint effusion	50.0% 3/6 • Number of events 4 • 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.	50.0% 3/6 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders joint swelling	50.0% 3/6 • Number of events 3 • 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.	50.0% 3/6 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders muscle atrophy	83.3% 5/6 • Number of events 5 • 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.	16.7% 1/6 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders joint crepitation	33.3% 2/6 • Number of events 2 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders chondromalacia	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders chondropathy	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders exostosis	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders haemarthrosis	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders joint lock	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Musculoskeletal and connective tissue disorders plica syndrome	0.00% 0/6 • 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.	16.7% 1/6 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders tendonitis	0.00% 0/6 • 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.	16.7% 1/6 • Number of events 1 • 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.
Vascular disorders prehypertension	50.0% 3/6 • Number of events 3 • 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.	0.00% 0/6 • 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.