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

Must not be taking: Immunosuppressants, Antipsychotics

Disqualifiers: Diabetes, Cancer, Autoimmune disorders, others

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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy for individuals with full-thickness rotator cuff tears. The aim is to determine if injecting E-CEL UVEC® cells (also known as AB-207) during surgery can enhance healing and outcomes. It targets those whose rotator cuff tears have not improved with treatments such as physical therapy, medications, or injections. Participants must have a specific type of tendon tear identified by MRI and physical exams. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that E-CEL UVEC cells are likely to be safe for humans?

Previous studies have used E-CEL UVEC cells to research rotator cuff injuries. This cell therapy aims to enhance healing when combined with standard surgery. While detailed information on side effects remains unavailable, this trial is in an early phase. The primary goal is to assess safety and tolerability. Early-phase trials typically involve a small group of participants to closely monitor for any side effects. This careful approach helps identify risks before further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

E-CEL UVEC is unique because it utilizes cell therapy to target rotator cuff tears, a departure from traditional surgical repairs and physical therapy. This treatment involves injecting E-CEL UVEC cells directly into the supraspinatus muscle and tendon, potentially enhancing healing at the cellular level. Unlike standard treatments that primarily focus on mechanical repair, E-CEL UVEC leverages the regenerative potential of cells suspended in autologous plasma and dextran solutions, aiming to accelerate recovery and improve tendon integration. Researchers are excited about its potential to offer a more effective healing process for patients with rotator cuff injuries.

What evidence suggests that E-CEL UVEC could be an effective treatment for rotator cuff tears?

Research has shown that stem cell treatments might aid in healing rotator cuff injuries. This trial tests E-CEL UVEC cells, a type of stem cell, to determine if they can enhance recovery after surgery for rotator cuff tears. Early studies suggest these cells might help the body repair damaged tissue more effectively, potentially reducing pain and improving shoulder movement. Although these signs are promising, further research is necessary to confirm the effectiveness of E-CEL UVEC cells for this condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Scott Rodeo, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04057833

Study Details | NCT04057833 | E-CEL UVEC Cells As an ... This trial will investigate the safety and feasibility of local implantation of E-CEL UVEC cells along with standard-of-care arthroscopic surgical repair of ...

2. clinicaltrial.be clinicaltrial.be/en/details/4877?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthr... This trial will investigate the safety and feasibility of local implantation of E-CEL UVEC cells along with standard-of-care arthroscopic surgical repair of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9174670/

Advances in Stem Cell Therapies for Rotator Cuff Injuries - PMC Stem cell-based therapy is a promising therapeutic strategy that has great potential for rotator cuff healing.

4. news.hss.edu news.hss.edu/first-study-testing-cell-therapy-for-rotator-cuff-surgery-launches-at-hss/

First Study Testing Cell Therapy for Rotator Cuff Surgery ... “Arthroscopic shoulder surgery for rotator cuff tears is effective for relieving pain, restoring function and improving quality of life, but up ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0045753

Rotator Cuff Tears (DBCOND0045753) | DrugBank Online E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults ... Epidemiology and Outcomes of Upper Limb Surgery: Analysis of ...