Trial Outcomes & Findings for Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy (NCT NCT00755911)
NCT ID: NCT00755911
Last Updated: 2015-07-03
Results Overview
The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
12 months after tooth extraction
Results posted on
2015-07-03
Participant Flow
Participant milestones
| Measure |
Treatment
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
|
Control
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Baseline characteristics by cohort
| Measure |
Treatment
n=12 Participants
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
|
Control
n=12 Participants
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
53 years
STANDARD_DEVIATION 14 • n=7 Participants
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after tooth extractionThe primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)
Outcome measures
| Measure |
Tissue Repair Cells (TRC)
n=12 Participants
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
|
Control
n=12 Participants
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
|---|---|---|
|
Bone Regeneration
|
79 % bone height
Standard Deviation 10 • Interval 6.0 to 4.0
|
63 % bone height
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 12 months after tooth extractionThe secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures
Outcome measures
| Measure |
Tissue Repair Cells (TRC)
n=12 Participants
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
|
Control
n=12 Participants
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
|---|---|---|
|
Number of Participants Who Successfully Received Dental Implant Fixtures
|
12 participants
|
12 participants
|
Adverse Events
Experimental: Tissue Repair Cell (TRC)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sham Comparator: Control
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Tissue Repair Cell (TRC)
n=12 participants at risk
Subjects will receive TRC therapy plus Gelfoam carrier
|
Sham Comparator: Control
n=12 participants at risk
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
|---|---|---|
|
Surgical and medical procedures
Stomach Ulcer
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Assault injury
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Experimental: Tissue Repair Cell (TRC)
n=12 participants at risk
Subjects will receive TRC therapy plus Gelfoam carrier
|
Sham Comparator: Control
n=12 participants at risk
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
|
|---|---|---|
|
Surgical and medical procedures
Soreness following aspiration
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Social circumstances
Anxiety prior to procedure
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Post extraction soreness
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pulled leg muscle
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Fractured tooth
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Discomfort near surgical site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Restoration defect
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Upper lip tingling
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Oral conidition requiring multiple extractions
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Infections and infestations
Post surgical infection
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Infection
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
General disorders
Flu
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Dislocated knee
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Swelling and tenderness in tooth extraction area
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Fractured tooth extracted
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Nervous system disorders
Sensitive tooth
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Post extraction pain
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Open incision due to sutures coming out
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Discomfort with mouth movement
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Slight incision opening
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Slight incision opening
|
0.00%
0/12 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Pressure in sinus following extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Fractured teeth extracted
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Non-restorable tooth extracted
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Nervous system disorders
Distress from theft
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Swelling and oozing following extraction
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Discomfort
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Implant cover screw fell out and was replaced
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Failed aspiration
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bruising aspiration site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Moderate-severe swelling following extraction
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Mild swelling and bruising following extraction
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fractured tooth
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Non-restorable teeth extracted
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Moderate bruising and swelling following implant uncovery
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Supporation from tip of nose
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Crown fell off
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Broken upper flipper
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cut tendon in hand
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fell down stairs and tore tendons in right foot
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Post-op bleeding at aspiration site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Social circumstances
Relocated to another state due to personal issues
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Implant cover screw fell out
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Eye disorders
Pink eye
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bruising following extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Fractured tooth
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Tissue near extaction site loose causing some tenderness
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Soreness in extraction site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Injury, poisoning and procedural complications
Choking while eating
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Acute pharyngitis
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Strep throat
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Swelling following extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Bruising following extraction
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Discomfort following implant uncovery
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Post-op bleeding at aspiration site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Gout
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Post-op bleeding at aspiration site
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Bruising and swelling following extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone exposure following extraction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Nervous system disorders
Sensitivity to sweet and cold
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Gastrointestinal disorders
Nausea from medication
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Injury, poisoning and procedural complications
Pain and leg cramping during aspiration
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Surgical treatment for addiction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Surgical and medical procedures
Broken flipper
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
General disorders
Acute pharyngitis
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
General disorders
Density in lungs
|
0.00%
0/12 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place