Connective Tissue Matrix for Rotator Cuff Tendinopathy

Phase 4

Recruiting

• Conditions: Tendinopathy; Rotator Cuff Tendinitis; Shoulder Pain; Rotator Cuff Tendinosis
• Interventions: Biological: CTM Boost; Biological: PRP

• Registration Number: NCT06160427
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary

The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.

Detailed Description

Rotator cuff tendinopathy (RCT), is a chronic degenerative process which causes both shoulder pain as well as limited range of motion. It is currently estimated that approximately 5% of RCT is being managed surgically, which highlights the importance of effective non-operative treatment strategies.

The advent of platelet rich plasma (PRP), a sample of blood drawn from a patient and concentrated to include mainly platelets and potent inflammatory mediators which promote healing, has shown promise as another treatment modality when injected at the site of tendon damage. Placenta-derived decellularized connective tissue matrix (CTM) may represent an alternative therapy for RCT. Placenta-derived biologics can be administered as an injection and have been shown to promote tenocyte proliferation and to reduce inflammation in vitro, thus potentially accelerating and enhancing tendon healing.

This study is being conducted to determine if injection of CTM Boost is non-inferior to injection of PRP with regard to pain and function at Month 6 post-injection in patients with rotator cuff tendinopathy.

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study Start: 2023-12-04
• Study First Posted: 2023-12-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2027-01-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patients aged 18-80 years old with rotator cuff tendinopathy
• A PRP or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection

Exclusion Criteria

• Patients with adhesive capsulitis
• Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
• Patients with joint instability
• History of shoulder surgery or corticosteroid injection in the past 3 months
• Patients with any medical conditions that affect healing, such as end-stage renal disease or uncontrolled diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTM Treatment	CTM Boost	2.0 cc (cubic centimeter) dose injection of CTM Boost will be administered by injection directly into the rotator cuff using a 20 gauge needle.
PRP Treatment	PRP	Each participant randomized to this arm will receive a single injection of Platelet Rich Plasma (PRP).

Primary Outcome Measures

Name	Time	Method
determine if injection of CTM Boost is non-inferior to injection of PRP	6 months	Mean Western Ontario Rotator Cuff Index (WORC) Score The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.

Secondary Outcome Measures

Name	Time	Method
assessment of superiority of CTM to PRP (if non-inferiority established)	6 months	serum levels of inflammatory cytokines IL-1β and TNF-α as well as serum level of Fibroblast growth factor (FGF)
safety of injection of CTM boost compared to PRP	6 months	number of adverse events
severity of tendinopathy	6 months	Magnetic Resonance Imaging (MRI)-based grading scale MRIs will be scored on rubric from 0-5: 0, no tendinopathy; 1, mild tendinopathy; 2, moderate tendinopathy; 3, moderate tendinopathy + partial thickness tear present; 4, severe tendinopathy +partial thickness tear present; 5, severe tendinopathy + full thickness tear present

Trial Locations

Locations (4)

AHN Wexford Hospital; 🇺🇸 Wexford, Pennsylvania, United States

Allegheny Health Network Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

AHN Wexford Health & Wellness Pavilion; 🇺🇸 Wexford, Pennsylvania, United States

Allegheny Health Network Federal North Medical Office Building; 🇺🇸 Pittsburgh, Pennsylvania, United States