Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

NCT04077190 | Completed DMC FDA Device

• 1 other identifier: RC-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (6)

• Long term Safety as indicated through adverse event rate between ADSC and TAU arms

  Adverse event rate

  at 24 months

• Long term Safety as indicated through adverse event rate between ADSC and TAU arms

  Adverse event rate

  at 36 months

• Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires

  Short form-36 score compared to baseline (total score = 800)

  at 24 months

• Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires

  Short form-36 score compared to baseline (total score = 800)

  at 36 months

• Long term efficacy of pain and function through ASES Shoulder Score health questionnaires

  ASES score compared to baseline (total score = 100)

  at 24 months

• Long term efficacy of pain and function through ASES Shoulder Score health questionnaires

  ASES score compared to baseline (total score = 100)

  at 36 months

Secondary Outcomes (1)

• Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness

  at 36 months

Study Arms (2)

adipose-derived stem cell injection

EXPERIMENTAL

Ultrasound guided injection of 5cc adipose derived stem cells

Device: Adipose-derived stem cells

cortisone injection

ACTIVE COMPARATOR

Ultrasound guided injection of cortisone

Device: cortisone injection

Interventions

Adipose-derived stem cells DEVICE

5cc adipose derived stem cells.

adipose-derived stem cell injection

cortisone injection DEVICE

cortisone injection

cortisone injection

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient completed participation in RC-001 (NCT02918136) study
• Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial.

You may not qualify if:

• none

Sponsors & Collaborators

• InGeneron, Inc.: lead

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

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• jason Hurd, MD

  Sanford Orthopedics & Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: September 4, 2019
• Study Start: August 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)