NCT02918136

Brief Summary

This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

September 26, 2016

Last Update Submit

February 8, 2021

Conditions

Rotator Cuff Tear - Partial Thickness

Outcome Measures

Primary Outcomes (1)

  • safety evaluation as indicated by collection of adverse events

    enrollment through 12months of follow-up

Study Arms (2)

adipose-derived stem cell injection

EXPERIMENTAL

ultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs)

Biological: Adipose derived regenerative cells

cortisone injection

ACTIVE COMPARATOR

ultrasound guided injection of cortisone

Drug: Cortisone Injectable

Interventions

Adipose derived regenerative cellsBIOLOGICAL
Also known as: ADRCs
adipose-derived stem cell injection
Cortisone InjectableDRUG
Also known as: steroid
cortisone injection

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 30-75 years of age.
  • Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion (AROM).
  • Subjects who have not responded to physical therapy treatments for at least six weeks.
  • Subjects with \> 70% passive range of motion (PROM).
  • Diagnosed with \>50% tear to supraspinatus muscle or \< 5mm separation assessed by MRI.
  • Diagnosed with a partial-thickness rotator cuff tear
  • The ability of subjects to give appropriate consent or have an appropriate representative available.

You may not qualify if:

  • Age \<30 or \> 75
  • Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
  • History of systemic malignant neoplasms within last 5 years.
  • History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.
  • Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
  • Subjects who are known to be HIV positive
  • Patients who have received a corticosteroid injection in rotator cuff site within last 3 months
  • Severe arthrosis of the glenohumeral or acromioclavicular joint
  • Irreparable rotator cuff tear (including rotator cuff tear arthropathy)
  • Fatty atrophy above Grade 2 in affected shoulder
  • Previous shoulder surgeries in affected shoulder
  • History of tobacco use within the last 3 months
  • Any contraindications to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
  • Patients on an active regimen of chemotherapy
  • Patients with a documented history of liver disease or an ALT value \>400
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanford Orthopedics and Sports Medicine - Fargo

Fargo, North Dakota, 58103, United States

Location

Sanford orthopedics and Sports Medicine - Sioux Falls

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (1)

  • Hurd JL, Facile TR, Weiss J, Hayes M, Hayes M, Furia JP, Maffulli N, Winnier GE, Alt C, Schmitz C, Alt EU, Lundeen M. 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. J Orthop Surg Res. 2020 Mar 30;15(1):122. doi: 10.1186/s13018-020-01631-8.

    PMID: 32238172DERIVED

MeSH Terms

Interventions

Steroids

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jason Hurd, M.D.

    Sanford Orthopedics & Sports Medicine - Sioux Falls, SD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

December 1, 2016

Primary Completion

July 31, 2018

Study Completion

December 13, 2018

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)