← Back to Search

Regenerative Medicine

ADRC Injection for Rotator Cuff Tears

N/A
Waitlist Available
Led By Jason Hurd, MD
Research Sponsored by InGeneron, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights

Study Summary

This trial is testing whether a single injection of ADRCs into partial-thickness rotator cuff tears is more effective and results in more functional improvement than a single corticosteroid injection in the same area.

Who is the study for?
Adults aged 30-75 with chronic partial-thickness tears in the rotator cuff who experience pain and limited motion, but haven't had recent shoulder surgery or steroid injections. Excluded are those with severe joint issues, full-thickness tears, certain medical conditions like cancer within the last 5 years, immune diseases requiring systemic treatment, or allergies to specific anesthetics.Check my eligibility
What is being tested?
The trial is testing if a single injection of adipose-derived regenerative cells (ADRCs) into the tear can improve shoulder function more effectively than a standard corticosteroid injection into the subacromial space for patients with partial-thickness rotator cuff tears.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, allergic reactions to components in ADRC preparation or anesthesia used during procedure. Corticosteroids might cause local tissue damage or weakening of tendons over time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Pain: VAS
Improvement or no worsening in supraspinatus strength
Secondary outcome measures
Mean improvement in VAS - Pain score
Mean improvement in WORC score
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
+2 more
Other outcome measures
Mean improvement in Rand Short Form-36 score
Measurement of EuroQoL-5D-5L (EQ-5D-5L)
Measurement of Shoulder Activity Level
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adipose Derived Regenerative CellsExperimental Treatment1 Intervention
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Group II: CorticosteroidActive Control1 Intervention
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.

Find a Location

Who is running the clinical trial?

InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
543 Total Patients Enrolled
Jason Hurd, MDPrincipal InvestigatorSanford Orthopedics & Sports Medicine

Media Library

Rotator Cuff Tendinitis Research Study Groups: Corticosteroid, Adipose Derived Regenerative Cells

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants currently enrolled in this experiment?

"Affirmative, the details on clinicaltrials.gov confirm this medical trial's ongoing recruitment process. The study was initially posted on May 13th 2019 and the most recent update occurred on May 27th 2022. All in all, 246 patients are needed to be recruited from 12 different sites."

Answered by AI

Are there a considerable number of health care institutions conducting this research in the U.S.?

"The current trial is housed in 12 different sites, including La Mesa, Phoenix and Doral. To reduce the strain of participating, we recommend selecting a clinic close to you."

Answered by AI

What goals is this trial seeking to fulfill?

"This 24-week trial seeks to measure the enhancement or maintenance of supraspinatus strength. Secondary objectives include determining the proportion of patients who experience a 14 mm reduction in VAS pain score, measuring mean improvement in patient's VAS pain scores compared to baseline, and assessing if there is any improvement/stability on MRC Muscle Scale for supraspinatus strength compared to baseline at week 24."

Answered by AI

Is the target demographic for this research project limited to those aged 45 and older?

"This clinical trial is open to patients with ages between 30 and 75 years old. Currently, there are 13 studies for people below 18 years of age and 138 for those aged 65 or above."

Answered by AI

Are there any available slots for individuals to participate in this clinical trial?

"Affirmative, according to the details found on clinicaltrials.gov, this study is actively seeking patients for enrollment. Initially posted in May of 2019 and last updated on May 27th 2022, 246 participants are needed from 12 different sites."

Answered by AI

Is it possible to join this investigation?

"This research trial is recruiting 246 patients who are between 30 and 75 years of age that have been experiencing rotator cuff tendinitis for a minimum of 3 months. Individuals must meet the following prerequisites: demonstrate at least 70% passive range of motion, present with a Visual Analogue Scale - Pain score higher than or equal to 30 mm, show evidence from either 1.5 Tesla (1.5T) or 3 Tesla (3T) MRI imaging taken within the last three months depicting ≥25% partial-thickness tear in their supraspinatus tendon, and most importantly give informed consent upon request."

Answered by AI

Who else is applying?

What site did they apply to?
Lotus Clinical Research, LLC
Sports and Orthopedic Center
Texas Plastic Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Lotus Clinical Research, LLC: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
2019. "Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03752827.
All > North Dakota
~28 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top