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

• Sponsor: OhioHealth (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02070484
• Collaborator: NuTech Medical, Inc (Industry)
• Enrollment: 6
• Locations: 2
• Arms: 2
• Duration (Months): 37.7
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spondylosis; Intervertebral Disk Displacement; Intervertebral Disk Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis	Biological: NuCel; Biological: Demineralized Bone Matrix	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Mar 24, 2017
• Actual Study Completion Date: Mar 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NuCel Stemcell allograft	Biological: NuCel
Active Comparator: Demineralized Bone Matrix (DBM) Demineralized Bone Matrix (DBM) bone graft substitute	Biological: Demineralized Bone Matrix

Outcome Measures

Primary Outcome Measures

1. 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.

2. Oswestry Disability Index [Baseline]

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

3. Oswestry Disability Index [1 month]

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

4. Oswestry Disability Index [2 months]

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

5. Oswestry Disability Index [3 months]

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

6. Oswestry Disability Index [6 months]

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

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
2	Grant Medical Center	Columbus	Ohio	United States	43215

Sponsors and Collaborators

• OhioHealth
• NuTech Medical, Inc

Investigators

• Principal Investigator: Joseph Shehadi, MD, OhioHealth

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 24, 2015

More Information

Publications

None provided.

• Responsible Party: Joseph A. Shehadi, MD, Principal Investigator, OhioHealth
• ClinicalTrials.gov Identifier: NCT02070484
• Other Study ID Numbers: OH2-13-0034
• First Posted: Feb 25, 2014
• Last Update Posted: Sep 28, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Joseph A. Shehadi, MD, Principal Investigator, OhioHealth: NuCel; Lumbar Spine; Degenerative Disease; Efficacy; Fusion
• Additional relevant MeSH terms: Spinal Stenosis; Spinal Diseases; Intervertebral Disc Degeneration; Bone Diseases; Spondylolisthesis; Musculoskeletal Diseases; Spondylosis; Intervertebral Disc Displacement; Spondylolysis

Study Results

Participant Flow

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Period Title: Overall Study
STARTED	3	3
COMPLETED	2	3
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)	Total
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix	Total of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	3 100%	6 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	2 66.7%	4 66.7%
Male	1 33.3%	1 33.3%	2 33.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Oswestry Disability Index (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	28.7	26.7	27.7

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One of three NuCel patients withdrew before 12 months; therefore, analysis comprises two NuCel patients and three DBM patients.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	8.0 (11.3)	15.3 (17.2)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated due to low enrollment; therefore, CT scans at 6 and 12 months were not conducted.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	0	0

3. Primary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	3	3
Mean (Standard Deviation) [units on a scale]	28.7 (3.1)	26.7 (7.5)

4. Primary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	15.5 (12.0)	26.7 (13.7)

5. Primary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	19.5 (17.7)	22.0 (9.6)

6. Primary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	10.0 (12.7)	25.7 (7.5)

7. Primary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

Arm/Group Title	NuCel	Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	7.5 (9.2)	14.7 (10.6)

Adverse Events

Time Frame	Adverse events were recorded through 12 months post-operatively
Arm/Group Title	NuCel		Demineralized Bone Matrix (DBM)
Arm/Group Description	Stemcell allograft NuCel		Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
All Cause Mortality
	NuCel		Demineralized Bone Matrix (DBM)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Serious Adverse Events
	NuCel		Demineralized Bone Matrix (DBM)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/3 (33.3%)
Gastrointestinal disorders
Prolonged hospitalization	0/3 (0%)	0	1/3 (33.3%)	1
Other (Not Including Serious) Adverse Events
	NuCel		Demineralized Bone Matrix (DBM)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.