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

Study Overview
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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).

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.

Official Title
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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

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Biological: BMP-655/ACS or Standard of Care
* Biological: BMP-655/ACS or Standard of Care
* Biological: BMP-655/ACS or Standard of Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Questionnaire |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff tear repair, open surgical technique, safety