Autologous Bone Marrow Mononuclear Cell Therapy for Autism: An Open Label Proof of Concept Study

Table 4

Adverse events monitored over the entire period of follow-up of 26 months.

Adverse events	Present during the period of follow-up		Absent during the period of follow-up
	Procedure related	Cellular transplantation related	Procedure related	Cellular transplantation related
Minor	(i) Spinal headache (3.6%); (ii) Nausea (10.7%); (iii) Vomiting (17.9%); (iv) Pain at the site of injection (7.1%); (v) Pain at the site of aspiration (7.1%)	None	(i) Bleeding at the site of injection; (ii) Bleeding at the site of aspiration	None
Major	None	(i) Seizures* (9%); (ii) Transient increase in hyperactivity (18.7%); (iii) Persistent increase in hyperactivity till six months (3.1%)	(i) Neurological deficits; (ii) Nerve root damage; (iii) Parasthesia in lower limb; (iv) Loss of sensation in lower limb; (v) Loss of motor function in the lower limbs; (vi) Hematoma at the site of injection; (vii) Hematoma at the site of aspiration; (viii) Local infection at the site of injection or aspiration; (ix) Meningismus or meningitis; (x) Systemic or brain infection; (xi) Bowel or bladder incontinence; (xii) Respiratory distress; (xiii) Cardiac failure	Allergic reaction

∗Seizures were considered to be an adverse event when seizures observed were new onset postintervention with no previous history or there was increased frequency or severity of seizures as compared to preintervention.