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

NCT04077190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-03

No results posted yet for this study

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

Interventions

DEVICE

Adipose-derived stem cells

5cc adipose derived stem cells.

DEVICE

cortisone injection

cortisone injection

Sponsors & Collaborators

  • InGeneron, Inc.

    lead INDUSTRY

Principal Investigators

  • jason Hurd, MD · Sanford Orthopedics & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-11-01
Completion
2021-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077190 on ClinicalTrials.gov