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Table 3. Toxicity after stem cell infusion
Fassas et al.
Trial 1 Trial 2
Early toxicity, until day 30
Allergy 14/15 9/9
Erythema 4 (grade 1) 1 (grade 1)
Fever 9 (grade 1-2) 4 (grade 2)
Hypotension 2 (grade 4) 2 (grade 4)
Bronchial spasm
2(grade 3)
Anaphylaxis 2 (grade 4) 2 (grade 4)
S serum sickness
1
Oral 7 (grade 1-3) 5 (grade 1-2)
Bleeding 1 (grade 3) 2 (grade 3)
Elevated liver enzymes 3 (grade 1) 4(grade 1-3)
VOD
1 mild
Infection 13/15 8/9
Fever 1 (grade 2) 1 (grade 2)
Bleeding 9 (grade 3) 4 (grade 3-4)
Pneumonia 3 (grade 3) 1 (grade 3)
UTI 2 (grade 2) 1 (grade 2)
Fungal 1 (grade 3) 1 (grade 4, death)
Late complications, days 30 to 100
Infection 3/15 6/9
Fever
1 (grade 2)
Bleeding 1 (grade 2) 1 (grade 2)
Sinusitis
1 (grade 2)
UTI
1 (grade 2)
Viral 1 (grade 3) 6(grade 3)
Pericarditis
1 (grade 3)
TTP
Late complications, beyond day 100
1 plasma exchange
Viral infection
2 (grade 2-3)
Hashimoto disease/hypothermia
1
Ten patients, six in trial 1 and four in trial 2, had evidence of neurologic
decompensation (Table 4), especially during the periods of infection, with
increases in EDSS scores. However, that was mild and only transient, and all those
patients resumed their previous scores within 30 to 60 days after stem cell infusion.
Hematologic recovery was rapid, and there was no secondary graft failure. The
median time to 500 neutrophils/uL was 10 (8-11) and 11 (10-13) days in trials 1
and 2, and the median time to 50,000 platelets/uL was 26 (19-36) and 28 (21-65)
days. The average number of days spent in hospital for SCT was 28 (±1.3) in trial
1 and 32 (±5) in trial 2 (P