Trial Outcomes & Findings for Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures (NCT NCT02020590)

Results Overview

The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment. A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

6 months

Results posted on

2021-11-10

Participant Flow

Of the 25 patients enrolled in the study (ICF signature), 22 patients were treated: * 2 patients were considered as non eligible before treatment * 1 patient withdrew consent before prior to Day 0

Participant milestones

Participant milestones
Measure	ALLOB® Implantation One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALLOB® Implantation n=22 Participants One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Age, Continuous	47.3 years STANDARD_DEVIATION 13.96 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	22 Participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Germany	9 participants n=5 Participants
BMI	26.73 kg/m^2 STANDARD_DEVIATION 4.676 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The efficacy analysis was conducted on the Per Protocol population (21 treated patients; one patient being excluded from the analysis due on a major protocol deviation)

The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment. A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).

Outcome measures

Outcome measures
Measure	ALLOB® Implantation n=21 Participants One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Percentage of Responders at 6 Months (Efficacy of ALLOB)	100 percent of patients Interval 86.71 to 100.0

Adverse Events

ALLOB® Implantation

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALLOB® Implantation n=22 participants at risk One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Infections and infestations implant site infection	4.5% 1/22 • Number of events 1 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)
Skin and subcutaneous tissue disorders angioedema	4.5% 1/22 • Number of events 1 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)
Skin and subcutaneous tissue disorders Urticaria	4.5% 1/22 • Number of events 1 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)

Other adverse events

Other adverse events
Measure	ALLOB® Implantation n=22 participants at risk One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Injury, poisoning and procedural complications Fall	9.1% 2/22 • Number of events 2 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)
Injury, poisoning and procedural complications Procedural pain	22.7% 5/22 • Number of events 5 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)
Metabolism and nutrition disorders Vitamin D Deficiency	9.1% 2/22 • Number of events 2 • 6 months Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)

Additional Information

Chief Medical Officer

Bone Therapeutics

Phone: +32 71 12 10 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place