Trial Outcomes & Findings for Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease (NCT NCT02070484)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

12 months

Results posted on

2018-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	NuCel Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Overall Study STARTED	3	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	NuCel Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NuCel n=3 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Oswestry Disability Index	28.7 units on a scale n=3 Participants	26.7 units on a scale n=3 Participants	27.7 units on a scale n=6 Participants

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	NuCel n=2 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	8.0 units on a scale Standard Deviation 11.3	15.3 units on a scale Standard Deviation 17.2

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	NuCel n=3 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	28.7 units on a scale Standard Deviation 3.1	26.7 units on a scale Standard Deviation 7.5

PRIMARY outcome

Timeframe: 1 month

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

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

Outcome measures

Outcome measures
Measure	NuCel n=2 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	15.5 units on a scale Standard Deviation 12.0	26.7 units on a scale Standard Deviation 13.7

PRIMARY outcome

Timeframe: 2 months

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

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

Outcome measures

Outcome measures
Measure	NuCel n=2 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	19.5 units on a scale Standard Deviation 17.7	22.0 units on a scale Standard Deviation 9.6

PRIMARY outcome

Timeframe: 3 months

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

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

Outcome measures

Outcome measures
Measure	NuCel n=2 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	10.0 units on a scale Standard Deviation 12.7	25.7 units on a scale Standard Deviation 7.5

PRIMARY outcome

Timeframe: 6 months

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

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

Outcome measures

Outcome measures
Measure	NuCel n=2 Participants Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 Participants Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Oswestry Disability Index	7.5 units on a scale Standard Deviation 9.2	14.7 units on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: 6 and 12 months

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

CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.

Outcome measures

Outcome data not reported

Adverse Events

NuCel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Demineralized Bone Matrix (DBM)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NuCel n=3 participants at risk Stemcell allograft NuCel	Demineralized Bone Matrix (DBM) n=3 participants at risk Demineralized Bone Matrix (DBM) bone graft substitute Demineralized Bone Matrix
Gastrointestinal disorders Prolonged hospitalization	0.00% 0/3 • Adverse events were recorded through 12 months post-operatively	33.3% 1/3 • Number of events 1 • Adverse events were recorded through 12 months post-operatively

Other adverse events

Adverse event data not reported

Additional Information

Josepha Shehadi, MD

OhioHealth

Phone: 614-220-5648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place