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

NCT ID: NCT04077190

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adipose-derived stem cell injection

Ultrasound guided injection of 5cc adipose derived stem cells

Group Type EXPERIMENTAL

Adipose-derived stem cells

Intervention Type DEVICE

5cc adipose derived stem cells.

cortisone injection

Ultrasound guided injection of cortisone

Group Type ACTIVE_COMPARATOR

cortisone injection

Intervention Type DEVICE

cortisone injection

Interventions

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Adipose-derived stem cells

5cc adipose derived stem cells.

Intervention Type DEVICE

cortisone injection

cortisone injection

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InGeneron, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jason Hurd, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Orthopedics & Sports Medicine

Locations

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Sanford Orthopedics and Sports Medicine - Fargo

Fargo, North Dakota, United States

Site Status

Sanford orthopedics and Sports Medicine - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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RC-003

Identifier Type: -

Identifier Source: org_study_id

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