NCT01122498

A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

A Phase 1, Randomized, Open-Label, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full-Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Repair

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
BIOLOGICAL	BMP-655/ACS+Standard of care or Standard of care	BMP-655/ACS 0.015mg/mL
BIOLOGICAL	BMP-655/ACS+Standard of care or Standard of care	BMP-655/ACS 0.05mg/mL
BIOLOGICAL	BMP-655/ACS+Standard of care or Standard of care	BMP-655/ACS 0.15mg/mL or 0.025mg/mL

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-05-13
• Last updated: 2013-02-22

Locations

9 sites across 1 country: Japan