Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

Randomized, Single-Blind, 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 Procedure

Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Biological: BMP-655/ACS or Standard of Care; Biological: BMP-655/ACS or Standard of Care; Biological: BMP-655/ACS or Standard of Care

Detailed Description

This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.

Patients already enrolled in the study, should continue to complete assessments as described in the protocol.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Pfizer Investigational Site
  • Hamburg, Germany, 20246
    • Pfizer Investigational Site
• Netherlands
  • Amsterdam, Netherlands
    • Pfizer Investigational Site
  • Hoofddorp, Netherlands, 2134 TM
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.

Exclusion Criteria:

• Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
• Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
• Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
• Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
• Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
• Subjects who are either unwilling or unable to undergo examination with closed MRI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arm A	Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information.; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information,
Experimental: 2; Arm B	Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information.; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information,
Experimental: 3; Arm C	Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information.; Biological: BMP-655/ACS or Standard of Care; Decision was made by Legal to withhold this information,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator Questionnaire	1 year

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): April 13, 2012
• Last Update Submitted That Met QC Criteria: April 12, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: safety; rotator cuff tear repair; open surgical technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 3202V1-1001