Spine Treatment Appraisal Report (STAR): Bone Marrow-Derived Stem Cells Improve Neurological Recovery in Participants With Spinal Cord Injury

Abstract

Srivastava RN, Agrahari AK, Singh A, Chandra T, Raj S. Effectiveness of bone marrow-derived mononuclear stem cells for neurological recovery in participants with spinal cord injury: a randomized controlled trial. Asian J Transfus Sci. 2019;13(2):120-128.

Study Type

Study Quality:

Visual Abstract

Risk of Bias:

Why Is This Study an Important Topic?

Traumatic spinal cord injuries have devasting consequences affecting individuals, caregivers and society. Current treatment options that substantially improve neurological recovery are limited. Clinical trials of new modalities treating traumatic spinal cord injuries, such as bone-marrow derived stem cells, are much needed.

What Was the Primary Clinical Question?

Does the addition of bone-marrow derived stem cells, compared to surgical stabilization or non-operative care, result in improved neurological outcomes in patients with SCI?

Study Characteristics

Population:	Included: SCI Patients 18-65 years, duration of injury <6 weeks, AIS-A grade, TL injury severity score ≥4, sagittal continuity of spinal cord and presence of cord hemorrhage on MRI. Excluded: Polytrauma patients with associated thoraco-abdominal injuries and/or head injury; medically unfit for surgery; other comorbid conditions such as osteoporosis, pressure sores (Grade III–IV), psychiatric illness; those taking steroids or other immune suppressants.
Intervention:	Group 1, Stem cell augmentation: Posterior instrumentation followed by infusion of autologous BM-derived stem cells as an adjuvant (n=70, mean age=31 years, 90% male)
Comparison:	Group 2, Spine stabilization: Posterior instrumentation (n=68, mean age 31 years, 85% male) Group 3, Non-operative care: Conservative management (n=55, mean age 33 years, 80% male)
Outcomes:	American Spinal Injury Association (ASIA) Impairment Scale (AIC) (higher=better) Sensory deficit (higher=better) Motor deficit (higher=better)
Time:	Follow-up: 1 year

Results

Result 1. Mean differences in Spinal Injury Association (ASIA) Impairment Scale 1 year following injury.

Result 2. Motor and Sensory Scores (higher = better) 1 year following injury.

	Stem Cells	Stabilization	Non-op
Motor	58.8 ± 10.7	54.3 ± 6.3	51.6 ± 5.1
Sensory	169.3 ± 18.6	160.8 ± 21.4	150.3 ± 16.9

How Will This Affect the Care of My Patients?

Surgery should be considered over non-operative care when indicated. In addition to surgical stabilization, one bone-marrow derived stem cells should also be considered.