Table II.

Summary of adverse events.

		Safety
Group	Patient number (sex, age)	TGF-β1 ELISA/PCR	Laboratory results	Adverse events
Dose level 1, 3 × 106 cells	001 (M, 77)	Normal	Normal	2 days post-dosing: 3–4 h after dinner, patient complained of itching and warming sensation in the injection area. Sensation subsequently disappeared spontaneously in a few hours
	002 (F, 62)	Normal	Normal	No adverse events
	003 (F, 59)	Normal	Normal	Patient experienced grade 2 hydrarthrosis(joint fluid collection) of the injected joint from day 14 until day 18 post-dosing, which was probably related to TG-C treatment. Patient was treated with aspiration, Nonsteroidal Anti-inflammatory Drug (NSAID), acetaminophen and resolved
	004 (F, 73)	Normal	Normal	No adverse events
Dose level 2, 1 × 107 cells	006 (F, 53)	Normal	Normal	1 day post-dosing: patient complained of pain, swelling and warming sensation of the injected joint. Prescribed NSAID at 8 days post-dosing (medication for 38 days). The symptom had disappeared at 45 days post-dosing
	007 (F, 52)	Normal	Normal	Afternoon of the day of dosing: patient had headache and a warming sensation in the injected joint. Symptoms spontaneously disappeared in a few hours
	008 (M, 69)	Normal	Normal	4–5 h post-dosing: patient had pain in the injected joint, which disappeared spontaneously in a few hours. Pain of the injected joint at 23 days post-dosing. Prescribed NSAID and acetaminophen from day 24 to day 30 post-dosing (for 7 days). Symptom was resolved
	009 (M, 60)	Normal	Normal	At 22 days post-dosing, patient had swelling and effusion (fluid collection) of the injected joint after hiking. Prescribed Etololac 600 mg (once a day) from day 22 to day 28 post-dosing. Symptoms were resolved
Dose level 3, 3 × 107 cells	010 (F, 71)	Normal	Normal	For 7 days after injection, patient felt stiffness and discomfort of knee. The symptoms disappeared without any treatment
	011 (M, 65)	Normal	Normal	From 1 day post-dosing, patient had swelling and dull pain. Hydroarthrosis and warmth was observed at the joint. Prescribed Acetaminophen 650 mg (3 times/day, for days 5–35 post-dosing), Celecoxib 200 mg (once a day, for days 11–35 post-dosing). Symptoms disappeared by day 40 post-dosing
	012 (M, 55)	Normal	Normal	For 2 weeks after injection, patient had dull pain and swelling of the injected knee. The symptoms disappeared without any treatment
	013 (F, 62)	Normal	Normal	There was swelling and mild fever on the day of injection. Hydroarthrosis was observed. Treated with Acetaminophen 650 mg (3 times/day, from 1-day post-dosing), Celecoxib 200 mg (once a day, for days 7–30 post-dosing). Symptoms disappeared by day 30 post-dosing

M, male; F, female; age, years.