Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02070484

Enrollment

Registered

2014-02-25

Start date

2014-02-28

Completion date

2017-03-24

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Intervertebral Disk Degeneration, Intervertebral Disk Displacement, Lumbar Degenerative Disc Disease, Musculoskeletal Diseases, Spinal Diseases, Spinal Stenosis, Spondylolisthesis, Spondylolysis, Spondylosis

Keywords

NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion

Brief summary

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

Interventions

BIOLOGICALNuCel

BIOLOGICALDemineralized Bone Matrix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Between the ages of 18 and 75 years * Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis * Failed conservative treatments * Low risk for non-union * Must be candidates for single-level, posteriolateral lumbar spine fusion * Must be able and willing to give Informed Consent * English-speaking

Exclusion criteria

* Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013) * Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%) * Documented osteoporosis * Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on * Back pain due to infection, tumour, or metabolic bone disease * Terminal disease, such as HIV infection, neoplasm * Autoimmune disease, such as rheumatoid arthritis * Morbid obesity (body mass index (BMI) of 35 kg/m2) * Major psychiatric illness in the last year * History of alcohol or drug abuse in the last year * Pregnant women

Design outcomes

Primary

Measure	Time frame	Description
Oswestry Disability Index	12 months	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.

Secondary

Measure	Time frame	Description
Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion	6 and 12 months	CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.

Countries

United States

Participant flow

Participants by arm

Arm	Count
NuCel Stemcell allograft NuCel	3
Demineralized Bone Matrix (DBM) Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix	3
Total	6

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	NuCel	Demineralized Bone Matrix (DBM)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	3 Participants	3 Participants	6 Participants
Oswestry Disability Index	28.7 units on a scale	26.7 units on a scale	27.7 units on a scale
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	2 Participants	2 Participants	4 Participants
Sex: Female, Male Male	1 Participants	1 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 3
other Total, other adverse events	0 / 3	0 / 3
serious Total, serious adverse events	0 / 3	1 / 3