Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

NCT03752827 | Active Not Recruiting DMC FDA Device

• 1 other identifier: RC-002
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

Conditions

Rotator Cuff Tear; Rotator Cuff Tendinitis

Keywords

rotator cuff tear; adipose-derived regenerative cells; adipose-derived stem cells; partial rotator cuff tears; corticosteroid

Outcome Measures

Primary Outcomes (2)

• Improvement in Pain: VAS

  ≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)

  24 weeks

• Improvement or no worsening in supraspinatus strength

  supraspinatus strength on the MRC Muscle Scale compared to baseline For supraspinatus strength on the MRC Muscle Scale compared to baseline • For subjects with normal supraspinatus strength (MRC Muscle Scale = 5\] at baseline: no worsening in supraspinatus strength on the MRC Muscle Scale compared to baseline

  24 weeks

Secondary Outcomes (5)

• Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS

  24 weeks

• Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale

  24 weeks

• Mean improvement in VAS - Pain score

  12 and 24 weeks

• Mean improvement in WORC score

  12 and 24 weeks

• Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale

  24 weeks

Other Outcomes (5)

• Mean improvement in Rand Short Form-36 score

  24 weeks

• Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction)

  24 weeks

• Measurement of EuroQoL-5D-5L (EQ-5D-5L)

  24 weeks

Study Arms (2)

Adipose Derived Regenerative Cells

EXPERIMENTAL

Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear

Device: Adipose Derived Regenerative Cells

Corticosteroid

ACTIVE COMPARATOR

Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.

Drug: Corticosteroid

Interventions

Adipose Derived Regenerative Cells DEVICE

Adipose-derived regenerative cells isolated with the Transpose Ultra system

Adipose Derived Regenerative Cells

Corticosteroid DRUG

Corticosteroid injection into subacrominal space

Corticosteroid

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 30-75 years of age (inclusive).
• Subjects have a minimum of three (3) months of clinical symptoms consistent with a partial-thickness rotator cuff tear including but not limited to pain, muscle weakness, or limited active range of motion (AROM).
• Subjects have \> 70% passive range of motion (PROM) of the index shoulder.
• Subjects have a baseline VAS - Pain score of ≥ 30 mm.
• Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 1.5 Tesla (1.5T) or a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator.
• Subjects can give appropriate consent.

You may not qualify if:

• Age \< 30 or \> 75.
• Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue.
• Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months.
• Subjects who have received more than one (1) previous corticosteroid injections or any biologic treatment in the index subacromial bursa within the past 6 months.
• Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
• Subjects with a full-thickness tear of the rotator cuff.
• Subjects who have undergone major surgery on the affected shoulder meeting one of the following criteria:
• Performed as treatment for (or required manipulation of) the rotator cuff. Examples include, but are not limited to, subacromial decompression, rotator cuff repair, SLAP repair, arthroplasty and fracture fixation with implants that involve or penetrate the rotator cuff; OR
• Performed using implants that interfere with MR visualization and/or evaluation of the supraspinatus tendon (e.g., biceps tenodesis); OR
• Performed in/on the glenohumeral joint, subacromial space, or acromioclavicular joint within the last 3 years (e.g. soft tissue Bankart repairs performed \>3 years ago may still qualify).
• Subjects who were diagnosed with or treated for adhesive capsulitis of the index shoulder within the last 5 years.
• Subjects with current cervical radiculopathy impacting the index shoulder.
• Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
• Subjects with any contraindication to MRI scan according to MRI guidelines, or who are unwilling to undergo MRI procedures.
• Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study- required assessments.

Sponsors & Collaborators

• InGeneron, Inc.: lead

Study Sites (14)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Sports and Orthopedic Center

Coral Springs, Florida, 33067, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Shrock Clinical Research

Fort Lauderdale, Florida, 33316, United States

Location

Andrews Institute for Orthopaedics and Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Georgia Institute for Clinical Research

Marietta, Georgia, 30060, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58103, United States

Location

Sanford Orthopedic Clinic/Research

Sioux Falls, South Dakota, 57104, United States

Location

HD Research

Houston, Texas, 77041, United States

Location

Texas Plastic Surgery

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is a double-blinded trial in which the subject, post-procedural investigator and imaging core laboratory radiologists are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: May 13, 2019
• Primary Completion: November 30, 2023
• Study Completion: December 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)