Table 5.
Safety assessment of mesenchymal stem cells infusion in study subjects
| Serious adverse events (SAE) | Pt 1 | Pt 2 | Pt 3 | Pt 4 | Pt 5 | Pt 6 | Pt 7 | Pt 8 | Pt 9 |
|---|---|---|---|---|---|---|---|---|---|
| Death | n | n | n | n | n | n | n | n | n |
| Required hospitalization | n | n | n | n | n | n | n | n | n |
| Life-threatening | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Total | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events | |||||||||
| Blood and lymphatic system disorders (y or n, grade) | |||||||||
| Leukocytosis | n | n | n | n | n | n | n | n | n |
| Lymph node pain | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Cardiac disorders (y or n, grade) | |||||||||
| Acute coronary syndrome | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Ear and labyrinth disorders (y or n, grade) | |||||||||
| Ear pain | n | n | n | n | n | n | n | n | n |
| Vertigo | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Endocrine disorders (y or n, grade) | |||||||||
| Hypothyroidism | n | n | n | n | n | n | n | n | n |
| Hyperparathyroidism | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Eye disorders (y or n, grade) | |||||||||
| Conjunctivitis | n | n | n | n | n | n | n | n | n |
| Dry eye | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Gastrointestinal disorders (y or n, grade) | |||||||||
| Abdominal pain | n | y, 1 | n | y, 1 | y, 1 | n | n | y, 1 | n |
| Dyspepsia | n | n | n | n | n | n | n | n | n |
| Diarrhea | n | n | n | n | n | n | n | n | n |
| Nausea | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| General disorders and administration site conditions (y or n, grade) | |||||||||
| Fatigue | n | n | n | n | n | n | n | n | n |
| Fever | n | n | n | n | n | n | n | n | n |
| Table 5: Continued | |||||||||
| Serious adverse events (SAE) | Pt 1 | Pt 2 | Pt 3 | Pt 4 | Pt 5 | Pt 6 | Pt 7 | Pt 8 | Pt 9 |
| Pain | n | n | n | n | n | n | n | n | n |
| Infusion site reaction | n | n | n | n | n | n | n | n | y, 2 |
| Any | n | n | n | n | n | n | n | n | n |
| Hepatobiliary disorders (y or n, grade) | |||||||||
| Hepatic failure | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Immune system disorders (y or n, grade) | |||||||||
| Allergic reaction | n | n | n | n | n | n | n | n | n |
| Anaphylaxis | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Infections and infestations (y or n, grade) | |||||||||
| Bladder infection | n | n | n | n | n | n | n | n | n |
| Catheter related infection | n | n | n | y, 2 | n | n | n | n | n |
| Peritoneal infection | n | n | y, 3 | n | n | n | n | n | n |
| Urinary tract infection | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Procedural complications (y or n, grade) | |||||||||
| Intraoperative skin injury | n | y, 2 | n | y, 2 | y, 2 | n | n | y, 2 | y, 2 |
| Any | n | n | n | n | n | n | n | n | n |
| Increased alanine aminotransferase | n | n | n | n | n | n | n | n | n |
| Increased alkaline phosphatase | n | n | n | n | n | n | n | n | n |
| Increased aspartate aminotransferase | n | n | n | n | n | n | n | n | n |
| Creatinine increased | n | n | n | n | n | n | n | n | n |
| Hemoglobin increased | n | n | n | n | n | n | n | n | n |
| Lymphocyte count decreased | n | n | n | n | n | n | n | n | n |
| Lymphocyte count increased | n | n | n | n | n | n | n | n | n |
| Platelet count decreased | n | n | n | n | n | n | n | n | n |
| Weight gain | n | n | n | n | n | n | n | n | n |
| Weight loss | n | y, 1 | y, 1 | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Metabolism and nutrition disorders (y or n, grade) | |||||||||
| Anorexia | n | n | n | n | n | n | n | n | n |
| Hyperkalemia | n | n | n | n | n | n | n | n | n |
| Hyponatremia | n | n | n | n | n | n | n | n | n |
| Hypokalemia | n | n | n | n | n | n | n | n | n |
| Hypoglycemia | n | n | n | n | n | n | n | n | n |
| Hypoalbuminemia | n | n | n | n | n | n | n | n | n |
| New-onset diabetes | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Table 5: Continued | |||||||||
| Serious adverse events (SAE) | Pt 1 | Pt 2 | Pt 3 | Pt 4 | Pt 5 | Pt 6 | Pt 7 | Pt 8 | Pt 9 |
| Musculoskeletal and connective tissue disorders (y or n, grade) | |||||||||
| Arthritis | n | n | n | n | n | n | n | n | n |
| Arthralgia | n | n | n | n | n | n | n | n | n |
| Back pain | n | n | n | n | n | n | n | n | n |
| Flank pain | n | n | n | y,1 | y,1 | n | n | n | y,1 |
| Any | n | n | n | n | n | n | n | n | n |
| Neoplasms benign, malignant and unspecified include cysts and polyps (y or n, grade) | |||||||||
| Benign | n | n | n | n | n | n | n | n | n |
| Malignant | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Nervous system disorders (y or n, grade) | |||||||||
| Cognitive disturbance | n | n | n | n | n | n | n | n | n |
| Dizziness | n | n | n | n | n | n | n | n | n |
| Headache | n | n | n | y,1 | n | n | n | n | n |
| Seizure | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Psychiatric disorders (y or n, grade) | |||||||||
| Anxiety | n | n | n | n | n | n | n | n | n |
| Confusion | n | n | n | n | n | n | n | n | n |
| Depression | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Renal and urinary disorders (y or n, grade) | |||||||||
| Urinary frequency | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Reproductive system and breast disorders (y or n, grade) | |||||||||
| Breast pain | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Respiratory, thoracic, and mediastinal disorders (y or n, grade) | |||||||||
| Allergic rhinitis | n | n | n | n | n | n | n | n | n |
| Cough | n | n | n | n | y,1 | n | n | n | n |
| Dyspnea | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Skin and subcutaneous tissue disorders (y or n, grade) | |||||||||
| Pruritus | n | n | n | n | n | n | n | n | n |
| Eczema | n | n | n | n | n | n | n | n | n |
| Any | n | n | n | n | n | n | n | n | n |
| Vascular disorders (y or n, grade) | |||||||||
| Any | n | n | n | n | n | n | n | n | n |
| Total | 0 | 3 | 2 | 5 | 4 | 0 | 0 | 2 | 3 |
Pt; Patient, y; Yes, n; No. Adverse events were categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.