Lipogems for Shoulder Pain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Shoulder Pain+3 MoreLipogems - Device
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new treatment for shoulder pain in people with chronic spinal cord injury. The new treatment is an injection of fat tissue, and the study will compare it to the standard-of-care corticosteroid injection.

Eligible Conditions
  • Shoulder Pain
  • Spinal Cord Injury
  • Tendinopathy
  • Rotator Cuff Tears

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6 months

6 months
Change in Numerical Rating Scale
Patient Global Impression of Change
Shoulder
Quantitative Ultrasound of the Supraspinatus Tendon
Ultrasound Shoulder Pathology Rating Scale
Wheelchair User's Shoulder Pain Index

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Corticosteroid
1 of 2
Micro-Fragmented Adipose Tissue
1 of 2

Active Control

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Lipogems · No Placebo Group · Phase 2

Micro-Fragmented Adipose Tissue
Device
Experimental Group · 1 Intervention: Lipogems · Intervention Types: Device
Corticosteroid
Drug
ActiveComparator Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipogems
2017
Completed Phase 2
~150

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Kessler FoundationLead Sponsor
155 Previous Clinical Trials
10,291 Total Patients Enrolled
2 Trials studying Shoulder Pain
16 Patients Enrolled for Shoulder Pain

Eligibility Criteria

Age 18 - 70 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rotator cuff disease is pain located in the front of the shoulder, which is confirmed by tendinopathic changes on an ultrasound.
This person cannot walk without assistance, except for when they are using their wheelchair for exercise, and relies on their wheelchair for most forms of mobility.
Neurological impairment that has lasted for at least 12 months and is located between the C6 and L5 vertebrae.
Currently experiences chronic shoulder pain due to rotator cuff disease, which has not improved after at least 6 months of conservative treatment.
Most people experience at least some level of shoulder pain in the week before their visit to the clinic

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Kessler Foundation100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%