2.5 Million cells/kg

5 Million cells/kg

System Organ Class (SOC)

Cell
(N=10)

Events (Patients)

Control
(N=10)

Events (Patients)

Cell
(N=10)

Events (Patients)

Control
(N=10)

Events (Patients)

Treatment Emergent Adverse Events

43 (5)

26 (6)

32 (6)

13 (6)

Blood and lymphatic system disorders

1 (1)

-

1 (1)

-

     Anaemia

1 (1)

-

1 (1)

-

Endocrine disorders

1 (1)

-

-

-

     Adrenal insufficiency

1 (1)

-

-

-

Gastrointestinal disorders

17 (4)

9 (4)

10 (4)

3 (3)

     Constipation

4 (2)

2 (1)

-

1 (1)

     Vomiting

1 (1)

1 (1)

2 (1)

1 (1)

     Abdominal pain

4 (1)

1 (1)

1 (1)

-

     Nausea

2 (2)

-

1 (1)

-

     Abdominal pain upper

1 (1)

-

2 (1)

-

     Ascites

2 (1)

1 (1)

-

-

     Diarrhoea

-

1 (1)

2 (1)

-

     Haematochezia

1 (1)

1 (1)

-

-

     Abdominal distension

-

-

1 (1)

-

     Aphthous stomatitis

-

-

-

1 (1)

     Gastric ulcer

-

1 (1)

-

-

     Haematemesis

-

-

1 (1)

-

     Haemorrhoids

-

1 (1)

-

-

     Rectal prolapse

1 (1)

-

-

-

     Stomatitis

1 (1)

-

-

-

General disorders and administration site conditions

9 (4)

5 (2)

3 (3)

5 (2)

     Pyrexia

4 (2)

4 (2)

1 (1)

4 (2)

     Oedema peripheral

2 (2)

1 (1)

1 (1)

1 (1)

     Chest pain

1 (1)

-

-

-

     Disease progression

1 (1)

-

-

-

     Fatigue

-

-

1 (1)

-

     Non-cardiac chest pain

1 (1)

-

-

-

Hepatobiliary disorders

-

-

1 (1)

-

     Hepatic cirrhosis

-

-

1 (1)

-

Infections and infestations

4 (2)

2 (2)

7 (4)

2 (2)

     Nasopharyngitis

-

1 (1)

-

1 (1)

     Urinary tract infection

-

1 (1)

1 (1)

-

     Cellulitis

-

-

1 (1)

-

     Peritonitis bacterial

2 (1)

-

-

-

     Bacteraemia

-

-

1 (1)

-

     Bronchopneumonia

-

-

1 (1)

-

     Herpes virus infection

1 (1)

-

-

-

     Infectious pleural effusion

-

-

1 (1)

-

     Pyelonephritis

-

-

1 (1)

-

     Sepsis

-

-

1 (1)

-

     Subcutaneous abscess

-

-

-

1 (1)

     Typhoid fever

1 (1)

-

-

-

Investigations

2 (2)

3 (1)

-

-

     Urine output decreased

2 (2)

-

-

-

     Blood bilirubin increased

-

1 (1)

-

-

     International normalized ratio increased

-

1 (1)

-

-

     Prothrombin time prolonged

-

1 (1)

-

-

Metabolism and nutrition disorders

1 (1)

2 (2)

-

-

     Diabetes mellitus

-

2 (2)

-

-

     Hyperkalaemia

1 (1)

-

-

-

Musculoskeletal and connective tissue disorders

3 (2)

1 (1)

-

-

     Arthralgia

2 (1)

1 (1)

-

-

     Muscle spasms

1 (1)

-

-

-

Nervous system disorders

3 (3)

-

3 (2)

2 (1)

     Hepatic encephalopathy

2 (2)

-

3 (2)

1 (1)

     Loss of consciousness

-

-

-

1 (1)

     Paraesthesia

1 (1)

-

-

-

Psychiatric disorders

-

1 (1)

-

-

     Abnormal behaviour

-

1 (1)

-

-

     Insomnia

-

-

-

-

Renal and urinary disorders

1 (1)

-

2 (2)

-

     Haematuria

-

-

1 (1)

-

     Renal failure

-

-

1 (1)

-

     Renal failure acute

1 (1)

-

-

-

Reproductive system and breast disorders

-

1 (1)

-

-

     Gynaecomastia

-

1 (1)

-

-

Respiratory, thoracic and mediastinal disorders

1 (1)

1 (1)

4 (2)

1 (1)

     Cough

-

1 (1)

1 (1)

1 (1)

     Hydrothorax

-

-

1 (1)

-

     Pleural effusion

1 (1)

-

-

-

     Pneumonitis

-

-

1 (1)

-

     Tachypnoea

-

-

1 (1)

-

Skin and subcutaneous tissue disorders

-

1 (1)

-

-

     Acne

-

1 (1)

-

-

     Eczema

-

-

-

-

Vascular disorders

-

-

1 (1)

-

     Artery dissection

-

-

1 (1)

-