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NCT Number: NCT04077190

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford Orthopedics and Sports Medicine - Fargo, Fargo, North Dakota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adipose-derived stem cells

Device

5cc adipose derived stem cells.

cortisone injection

Device

cortisone injection

Primary outcomes

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

    Time frame: at 24 months

    Adverse event rate

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

    Time frame: at 36 months

    Adverse event rate

  3. 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)

  4. 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)

  5. 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)

  6. 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)

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

    Time frame: at 36 months

    Percentage improvement in tendon tear size and thickness

Sponsors and collaborators

Lead sponsor

InGeneron, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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