Cell Therapy for Rotator Cuff Tears

Overseen By Camila Carballo, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hospital for Special Surgery, New York

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 0 weeks (at time of surgery)

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 1b investigator-initiated clinical trial that 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. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and cell therapy, it's best to discuss your current medications with the trial team to ensure safety and compatibility.

What data supports the effectiveness of the treatment E-CEL UVEC, AB-207 for rotator cuff tears?

Research shows that injections of stem cells derived from umbilical cord blood can help heal rotator cuff tears in animal models, improving tendon condition and movement ability. This suggests that similar cell-based treatments might be effective for rotator cuff injuries. ^{1 2 3 4 5}

Is cell therapy for rotator cuff tears safe for humans?

The safety of cell therapy for rotator cuff tears in humans has not been directly addressed in the provided studies, which focus on animal models and do not report safety data for humans. ^{1 2 3 6 7}

How does the cell therapy treatment for rotator cuff tears differ from other treatments?

This cell therapy uses mesenchymal stem cells (special cells that can develop into different types of tissues) derived from human umbilical cord blood, which are injected directly into the rotator cuff tendon to promote healing without the need for surgery. This approach is unique because it focuses on regenerating the tendon tissue itself, rather than just repairing it, and it avoids the need for surgical intervention. ^{1 3 8 9 10}

Research Team

Scott Rodeo, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

E-CEL UVEC cells are delivered to the tendon repair site and muscle adjacent to the tendon repair site during arthroscopic rotator cuff repair

0 weeks (at time of surgery)

1 visit (in-person)

Short-term Follow-up

Participants are monitored for local and systemic safety and toxicity via adverse event logs

11 days

Post-operative monitoring

Long-term Follow-up

Participants are monitored for long-term safety, shoulder strength, patient-reported outcomes, and re-tear rate via clinical and MRI evaluation

1 year

Regular intervals up to 1 year

Treatment Details

Interventions

• E-CEL UVEC

Trial Overview 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.

Participant Groups

Group I: E-CEL UVEC Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Angiocrine Bioscience

Industry Sponsor

Trials

6

Recruited

250+

References

1. United States pubmed.ncbi.nlm.nih.gov

Extracellular Vesicles Delivered by Injectable Collagen Promote Bone-Tendon Interface Healing and Prevent Fatty Degeneration of Rotator Cuff Muscle. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of Full-Thickness Rotator Cuff Tendon Tear Using Umbilical Cord Blood-Derived Mesenchymal Stem Cells and Polydeoxyribonucleotides in a Rabbit Model. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Regeneration of Full-Thickness Rotator Cuff Tendon Tear After Ultrasound-Guided Injection With Umbilical Cord Blood-Derived Mesenchymal Stem Cells in a Rabbit Model. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Subacromial Bursa-Derived Cells Demonstrate High Proliferation Potential Regardless of Patient Demographics and Rotator Cuff Tear Characteristics. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Preparation Techniques for Isolating Subacromial Bursa-Derived Cells as a Potential Augment for Rotator Cuff Repair. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Regenerative effects of mesenchymal stem cells by dosage in a chronic rotator cuff tendon tear in a rabbit model. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Isolation and characterization of 2 new human rotator cuff and long head of biceps tendon cells possessing stem cell-like self-renewal and multipotential differentiation capacity. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Muscle cell-mediated gene delivery to the rotator cuff. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Rotator Cuff Tendon Healing Using Human Dermal Fibroblasts: Histological and Biomechanical Analyses in a Rabbit Model of Chronic Rotator Cuff Tears. [2021]