Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

NCT06505135 | Enrolling By Invitation Phase 1

• 1 other identifier: SHS-Ort-1-2004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy

Keywords

Stem cells

Outcome Measures

Primary Outcomes (1)

• Patient reported outcome of Oxford shoulder score

  A difference in 8 points from the oxford shoulder score questionnaire. The Oxford Shoulder Score comprises twelve items: four assessing the degree of pain and eight evaluating function. Each item is rated on a 5-point Likert scale, where 0 indicates the worst outcome, and 4 indicates the best. The scores from these 12 items are summed to produce a total score ranging from 0 to 48

  From inclusion and until 12 months after operation

Secondary Outcomes (5)

• Clinical healing of the shoulder

  12 months post surgery

• Radiological healing

  baseline, 6 and 12 months post-surgery

• Functioning of the supraspinatus muscle with improved muscle strain

  baseline, 3, 6 and 12 months post-surgery

• Oxford shoulder score

  baseline, 3, 6 and 12 months post-surgery

• Quality of life (EQ5D)

  baseline, 3, 6 and 12 months post-surgery

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

ROTATOR CUFF SURGERY Rotator cuff tendon suture is carried out at Hospital Sønderjylland according to inclusion criteria. Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors.

Other: Standard care

Stem-cell treatment

EXPERIMENTAL

HARVEST OF ADIPOSE TISSUE Harvest of adipose tissue from abdominal subcutis and the cell preparation will be performed in the approved lipoplasty system.This lipoaspirate will be processed in the dedicated adipose tissue-processing device. Cell clusters collected at the top of the adipose tissue-processing device undergo a second size reduction by being passed through a size reduction filter. The final product (approximately 60-100 mL) is then concentrated and collected into a 10-mL syringe for subsequent use. HARVEST OF MUSCLE BIOPSY FROM THE SUPRASPINATUS MUSCLE A biopsy of 0.1-0.2 g muscle is obtained from the supraspinatus muscle to estimate preoperative muscle fiber atrophy, intracellular lipid accumulation, mitochondrial dysfunction, inflammation and reduced regenerative capacity. The muscle biopsy specimens will be taken near the muscular tendinous junction during routine exposure or arthroscopy of the glenohumeral region.

Biological: Stem-cell treatment

Interventions

Stem-cell treatment BIOLOGICAL

In the cell treatment group of patients, injection of the cell suspension will be performed at the end of the surgical procedure. Fluid is carefully aspirated via the anterior outflow cannula, and autologous micro-fragmented adipose tissue is injected in dry arthroscopy conditions from the lateral portal while maintaining a subacromial view from the posterior portal. 10 mL of the stem cells suspension will be injected into the supraspinatus muscle at four predefined sites at the musculo-tendinous junction of the supraspinatus muscle. For each injection site, 1.5 mL of the suspension will be injected using an 18-gauge syringe.

Stem-cell treatment

Standard care OTHER

Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors

Standard Care

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs and symptoms compatible with a traumatic RCT
• MR verified supraspinatus tear
• Reparable lesion with tendon retraction \< 2 cm.
• Fatty infiltration level 0-2 (out of 5) according to Fuchs et al. and based on Goutalliers classification
• No history of inflammatory disease
• ASA score \< 3 (patients in good health)
• Signed consent to the study (including use of relevant data from the patient's electronic health records)

You may not qualify if:

• No MRI of the shoulder
• Former surgery in the affected shoulder
• Signs of infection
• Immunosuppression (due to clinical condition or medical therapy)
• History of inflammatory disease
• Malignancy within 5 years
• Previous radiotherapy to the shoulder
• BMI under 18
• BMI above 35
• Coagulopathy
• Non-Danish speaking patients

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Orthopaedic Research Unit, Department of Orthopaedics, Hospital Sønderjylland, Region of Southern Denmark.

Sønderborg, Danmark, 6400, Denmark

Location

Related Publications (1)

• Cartuliares MB, Hejbol EK, Schroder HD, Pedersen AK, Frich LH. Stem cell treatment for regeneration of the rotator cuff: study protocol for a prospective single-center randomized controlled trial (Lipo-cuff). Trials. 2024 Oct 19;25(1):696. doi: 10.1186/s13063-024-08557-0.

  PMID: 39427182 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lars H. Frick, Prof.

  University of Hospital of Southern Denmark - Aabenraa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a prospective, randomized interventional trial to evaluate the effectoutcome of the treatment of rotator cuff tear with combined standard surgical attachment (standard care) of the supraspinatus tendon and supplementary injection of micro-fragmented tissue into the supraspinatus muscle (cell treatment group) compared to standard care only.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)