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Cell Therapy for Rotator Cuff Tears
Phase 1
Waitlist Available
Led By Scott Rodeo, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 45-70 years old
Diagnosis of full-thickness supraspinatus tendon tear by MRI and physical examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative 90 day to 1 year
Awards & highlights
Study Summary
This trial will evaluate the safety and feasibility of E-CEL UVEC cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair.
Who is the study for?
Adults aged 45-70 with a full-thickness supraspinatus tendon tear confirmed by MRI, who have tried non-operative treatments like physical therapy and medications without success. Excluded are those with severe arthritis signs on MRI, extreme BMI values, diabetes or metabolic disorders, recent cancer (except certain treated skin cancers), autoimmune diseases, HIV, pregnancy, allergies to bovine proteins, other significant shoulder issues or trauma.Check my eligibility
What is being tested?
The trial is testing the safety and potential benefits of E-CEL UVEC cells in improving healing after arthroscopic surgery for rotator cuff tears. These cells will be applied directly to the tendon repair site and adjacent muscle during surgery.See study design
What are the potential side effects?
Since this is an early-phase trial focusing on safety and feasibility of E-CEL UVEC cell therapy for rotator cuff repair, specific side effects are being studied but may include local reactions at the injection site or immune responses due to cell therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 70 years old.
Select...
I have a complete tear in my shoulder tendon confirmed by MRI and physical exam.
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My muscle degeneration is mild to moderate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative 90 day to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative 90 day to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Short-term safety
Secondary outcome measures
Long-term safety
MRI
PROMS
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: E-CEL UVECExperimental Treatment1 Intervention
Patients will receive an injection of the Cell therapy vehicle into their supraspinatus muscle and tendon at the time of rotator cuff repair.
E-CEL UVEC cells suspended in autologous plasma and combined with thrombin at the implantation site (tendon delivery).
E-CEL UVEC cells suspended in 6.0% Dextran 40 and 10.0% human serum albumin (HSA) (infusion solution) (muscle delivery).
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,344 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
508 Patients Enrolled for Rotator Cuff Tears
Angiocrine BioscienceIndustry Sponsor
4 Previous Clinical Trials
194 Total Patients Enrolled
Scott Rodeo, MDPrincipal InvestigatorHospital for Special Surgery, New York
2 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
56 Patients Enrolled for Rotator Cuff Tears
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to repair my rotator cuff before.I have been diagnosed with diabetes or another metabolic disorder.I know my HIV status.You currently use products that contain nicotine.I have been diagnosed with an autoimmune disorder.I do not have diabetes, recent cancer, immune, psychiatric or severe physical conditions that could affect my recovery.I am between 45 and 70 years old.I have a complete tear in my shoulder tendon confirmed by MRI and physical exam.I've tried standard treatments like physical therapy and medications for my tendon tear without success.I had cancer before, but if it was cervical carcinoma in situ or skin cancer treated with surgery, I am still eligible.I have had a serious injury or fracture in my arm.You are unable to follow the instructions for recovery after surgery.You are allergic to cow proteins.I have a tear in a shoulder tendon that is not the supraspinatus.My shoulder MRI shows clear arthritis signs.I have been diagnosed with a sudden tendon tear.Your tendon has moved 1 to 3 centimeters on an MRI.My BMI is either below 20 or above 35.My muscle degeneration is mild to moderate.I don't have major pain or trouble moving because of a tendon tear.
Research Study Groups:
This trial has the following groups:- Group 1: E-CEL UVEC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to sign up for this medical study?
"To qualify for the study, subjects must present with degeneration and be within 45 to 70 years of age. The research team is looking to enrol around 20 participants."
Answered by AI
To what extent is E-CEL UVEC detrimental to human health?
"Our evaluative score for E-CEL UVEC was 1, as this is a Phase 1 trial, therefore only limited evidence exists to corroborate its safety and efficacy."
Answered by AI
Are there still openings for enrolment in this scientific exploration?
"As per the information on clinicaltrials.gov, this research is no longer recruiting candidates; it had its initial posting in November 2019 and was last updated in August 2022. However, there are still 425 ongoing studies which are accepting patients at present."
Answered by AI
Is there an age restriction for participation in this trial?
"This clinical trial is limited to individuals aged between 45 and 70. In comparison, there are 78 separate studies that accept applicants below 18 years old and 311 for people above the age of 65."
Answered by AI
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