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Connective Tissue Matrix

CTM Shoulder Injection for Shoulder Osteoarthritis (HC22-1 Trial)

Phase 1
Waitlist Available
Research Sponsored by Indiana Hand to Shoulder Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients receiving a CTM injection for their initial treatment
Radiographic documented Glenohumeral osteoarthritis (grade 1-3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

HC22-1 Trial Summary

This trial is testing a tissue allograft to treat shoulder pain due to arthritis. It will measure pain and shoulder score at follow up intervals to determine success rate.

Who is the study for?
This trial is for individuals with shoulder osteoarthritis confirmed by X-rays. Participants will receive a single CTM injection guided by imaging to help with their condition. The study aims to track pain relief and improved shoulder function over time.Check my eligibility
What is being tested?
The trial tests the effectiveness of a human placental connective-tissue matrix (CTM) injection in managing shoulder osteoarthritis. Success rates are measured using pain and shoulder function scores at multiple intervals up to one year post-injection.See study design
What are the potential side effects?
Potential side effects were not explicitly provided, but as with any injection, there may be risks such as pain at the injection site, infection, allergic reactions or no improvement in joint symptoms.

HC22-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am getting a CTM injection as my first treatment.
Select...
I have been diagnosed with mild to moderate shoulder arthritis.

HC22-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Likert Pain Scale
Oxford Shoulder Score

HC22-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: CTM Shoulder InjectionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Indiana Hand to Shoulder CenterLead Sponsor
8 Previous Clinical Trials
320 Total Patients Enrolled
CTM BiomedicalIndustry Sponsor
3 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this scientific experiment?

"Absolutely. According to the information hosted on clinicaltrials.gov, this trial is actively enrolling patients since its original posting date of December 22nd 2022 and last update in December 6th 2023. 30 participants are required across a single site for participation in the study."

Answered by AI

Are there any enrollment opportunities remaining for this research initiative?

"Yes, clinicaltrials.gov's records demonstrate that this research endeavor is still recruiting participants. The trial was inaugurated on December 22nd 2022 and the information has been updated most recently as of December 6th 2023. Aspiring participants can apply at one single site with a total quota of 30 individuals needed for the study."

Answered by AI

Has the FDA sanctioned CTM Shoulder Injection as a viable treatment?

"As this is a Phase 1 trial, with limited evidence of efficacy and safety, CTM Shoulder Injection has been graded as a 1 on the Power team's scale."

Answered by AI

Who else is applying?

What site did they apply to?
Indiana Hand to Shoulder Center
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024