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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Arm A

Group Type EXPERIMENTAL

BMP-655/ACS or Standard of Care

Intervention Type BIOLOGICAL

Decision was made by Legal to withhold this information

2

Arm B

Group Type EXPERIMENTAL

BMP-655/ACS or Standard of Care

Intervention Type BIOLOGICAL

Decision was made by Legal to withhold this information.

3

Arm C

Group Type EXPERIMENTAL

BMP-655/ACS or Standard of Care

Intervention Type BIOLOGICAL

Decision was made by Legal to withhold this information,

Interventions

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BMP-655/ACS or Standard of Care

Decision was made by Legal to withhold this information

Intervention Type BIOLOGICAL

BMP-655/ACS or Standard of Care

Decision was made by Legal to withhold this information.

Intervention Type BIOLOGICAL

BMP-655/ACS or Standard of Care

Decision was made by Legal to withhold this information,

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No