Table 1. Demographic and Clinical Characteristics of Patients With Culture-Confirmed Bacterial Infections After Administration of ReGen Series Products From August 2017 to September 2018.
| Characteristic | Patients, No. (%) (N = 20) |
|---|---|
| Age, median (range), ya | 63 (2-89) |
| Sex | |
| Male | 13 (65) |
| Female | 7 (35) |
| Route and site of administrationb | |
| Intra-articular injection | 16 (80) |
| Lumbar or cervical spine | 8 (40) |
| Knee | 7 (35) |
| Shoulder | 4 (20) |
| Digits | 1 (5) |
| Intradiscal injection | 2 (10) |
| Intravenous infusion | 2 (10) |
| Otherc | 2 (10) |
| Infection siteb | |
| Bloodstream | 10 (50) |
| Jointd | 10 (50) |
| Spinee | 4 (20) |
| Skin and soft tissue | 2 (10) |
| Setting | |
| Pain clinic | 7 (35) |
| Orthopedic clinic | 6 (30) |
| Chiropractic clinic | 2 (10) |
| Ambulatory surgery center | 2 (10) |
| Spine treatment clinic | 1 (5) |
| Medical spa | 1 (5) |
| Rehabilitation and occupational medicine clinic | 1 (5) |
| Patient’s reported reason for seeking stem cell treatmentb | |
| Pain | 12 (60) |
| Osteoarthritis | 6 (30) |
| Rheumatoid arthritis | 2 (10) |
| Injury | 5 (25) |
| Otherf | 2 (10) |
| Unknown | 1 (5) |
| Organism(s) isolated from culturesb | |
| Escherichia coli | 14 (70) |
| Enterobacter cloacae complex | 7 (35) |
| Enterococcus faecalis | 6 (30) |
| Citrobacter species | 3 (15) |
| Proteus mirabilis | 1 (5) |
| Duration of initial hospitalization for infection, median (range), dg | 9 (3-58) |
a
Age was missing for 1 person.
b
Categories are not mutually exclusive.
c
Includes soft-tissue injection into the shoulder and nasal spray.
d
Includes osteomyelitis of the knee and septic arthritis of the knee and shoulder.
e
Includes epidural abscess, discitis, and vertebral osteomyelitis.
f
Includes shoulder adhesive capsulitis and quadriplegic limb spasticity.
g
Includes the 19 patients who were hospitalized. One did not require hospitalization.