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

August 2, 2022 updated by: InGeneron, Inc.

Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

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.

Study Overview

Detailed Description

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Sanford Orthopedics and Sports Medicine - Fargo
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford orthopedics and Sports Medicine - Sioux Falls

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adipose-derived stem cell injection
Ultrasound guided injection of 5cc adipose derived stem cells
5cc adipose derived stem cells.
Active Comparator: cortisone injection
Ultrasound guided injection of cortisone
cortisone injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time Frame: at 24 months
Adverse event rate
at 24 months
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time Frame: at 36 months
Adverse event rate
at 36 months
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Time Frame: at 24 months
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
Time Frame: at 36 months
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
Time Frame: at 24 months
ASES score compared to baseline (total score = 100)
at 24 months
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
Time Frame: at 36 months
ASES score compared to baseline (total score = 100)
at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: at 36 months
Percentage improvement in tendon tear size and thickness
at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: jason Hurd, MD, Sanford Orthopedics & Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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