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

NCT02918136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-02-11

No results posted yet for this study

Summary

This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries.

Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury

Conditions

  • Rotator Cuff Tear - Partial Thickness

Interventions

BIOLOGICAL

Adipose derived regenerative cells

DRUG

Cortisone Injectable

Sponsors & Collaborators

  • InGeneron, Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Hurd, M.D. · Sanford Orthopedics & Sports Medicine - Sioux Falls, SD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-07-31
Completion
2018-12-13

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 NCT02918136 on ClinicalTrials.gov