Trial Outcomes & Findings for Cell Therapy for Craniofacial Bone Defects (NCT NCT01616953)
NCT ID: NCT01616953
Last Updated: 2017-05-04
Results Overview
The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
4 months
Results posted on
2017-05-04
Participant Flow
Participant milestones
| Measure |
Ixmyelocel-T
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
Implant Placement Surgery
|
9
|
8
|
|
Overall Study
Implant Uncovery
|
8
|
8
|
|
Overall Study
6 Months Post-loading
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ixmyelocel-T
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
lack of bone and soft tissue
|
1
|
0
|
Baseline Characteristics
Cell Therapy for Craniofacial Bone Defects
Baseline characteristics by cohort
| Measure |
Ixmyelocel-T
n=10 Participants
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
n=8 Participants
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
n=5 Participants
|
31 years
n=7 Participants
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Pre-operative alveolar bone width
|
2.6 millimeters
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5 millimeters
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.8 millimeters
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.
Outcome measures
| Measure |
Ixmyelocel-T
n=9 Participants
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
n=8 Participants
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
Bone Regeneration
|
1.5 implant sites
Standard Deviation 1.5
|
3.3 implant sites
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 10 monthsThe ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.
Outcome measures
| Measure |
Ixmyelocel-T
n=10 Participants
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
n=8 Participants
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
Implant Stabilization
|
5 participants
|
8 participants
|
Adverse Events
Ixmyelocel-T
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Autogenous Bone Grafting
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixmyelocel-T
n=10 participants at risk
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
n=8 participants at risk
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
General disorders
Car accident
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
Other adverse events
| Measure |
Ixmyelocel-T
n=10 participants at risk
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
|
Autogenous Bone Grafting
n=8 participants at risk
Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
|---|---|---|
|
General disorders
Tooth sensitivity
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Infections and infestations
Infection of surgical site
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Musculoskeletal and connective tissue disorders
Mucosal ulcers
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
Surgical and medical procedures
Non-study implant failing
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Infections and infestations
Streptococcal pharyngitis
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Injury, poisoning and procedural complications
Self diagnosed inflamed rotator cuff
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Early suture removal
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Wisdom teeth impactions
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Non-study implant in sinus
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Infections and infestations
Inflammation of wrist
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Hernia
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Incision line opening
|
30.0%
3/10 • Number of events 3 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
20.0%
2/10 • Number of events 2 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
Infections and infestations
Swelling
|
30.0%
3/10 • Number of events 3 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Tooth fracture (unrelated to study)
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Unrelated bone graft procedure
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Root #9 extraction
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
Injury, poisoning and procedural complications
Left knee pain
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
Injury, poisoning and procedural complications
Torn ligament in ankle
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Wound dehiscence
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Pain in recipient site
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Membrane exposure
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Localized erythema
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Pain and dysesthesia in donor site
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Early implant failure
|
0.00%
0/10 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
|
General disorders
Abutment screw broke
|
10.0%
1/10 • Number of events 1 • August 2012 - June 2015
|
0.00%
0/8 • August 2012 - June 2015
|
|
General disorders
Implant restoration came off
|
20.0%
2/10 • Number of events 2 • August 2012 - June 2015
|
12.5%
1/8 • Number of events 1 • August 2012 - June 2015
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place