Placenta-Derived Tissue for Tennis Elbow

Overseen By Lexie Reissaus, B.S., CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana Hand to Shoulder Center

Disqualifiers: Previous elbow surgery, Systemic inflammatory conditions, Recent elbow injection, Recent elbow trauma, Workman's compensation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for tennis elbow, a common condition causing pain around the outside of the elbow. Researchers aim to determine if a single injection of placenta-derived tissue (CTM) can reduce pain and improve function. Participants will receive either this new treatment or a standard steroid injection (Celestone) for comparison. It is ideal for those who have experienced tennis elbow symptoms for at least six weeks without improvement from physical therapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that CTM Boost, a treatment derived from human connective tissue, is generally safe. Previous studies comparing CTM Boost to other treatments, such as platelet-rich plasma (PRP), indicate it performs equally well in reducing pain and improving function. This suggests it is likely safe, as it does not cause more side effects than other options.

In lab tests, CTM Boost interacted well with human cells, further suggesting its safety. The trial's Phase 2 status indicates that CTM Boost has demonstrated sufficient safety in earlier research to warrant continued testing. This is a positive sign for its potential safety in a broader population, though further testing is necessary for confirmation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tennis elbow?

Unlike the standard corticosteroid injections that provide temporary relief for tennis elbow by reducing inflammation, the CTM Boost injection offers a unique approach by using a placenta-derived connective tissue matrix. This matrix is believed to help repair and regenerate damaged tissues at the source of the pain. Researchers are excited about CTM Boost because it targets the underlying cause of tennis elbow, potentially leading to more lasting relief compared to the conventional treatments that primarily manage symptoms.

What evidence suggests that this trial's treatments could be effective for tennis elbow?

Research has shown that Connective Tissue Allograft (CTM), which participants in this trial may receive, might help reduce pain from tennis elbow, also known as lateral epicondylitis. Studies have found that CTM provides a supportive structure that aids tissue repair by allowing cells to attach and grow. Early results suggest that CTM can decrease elbow pain over time, as measured by a specific pain evaluation tool. This potential for aiding healing makes CTM a promising option for those with ongoing tennis elbow pain. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals suffering from Tennis Elbow, a type of tendinopathy. Specific eligibility criteria are not provided, but typically participants would need to have symptoms consistent with Tennis Elbow and be suitable candidates for the treatments being tested.

Inclusion Criteria

I have had tennis elbow symptoms for at least 6 weeks.

I haven't felt better after 6 weeks of physical therapy.

I can go to the Indiana Hand to Shoulder Center or its satellite locations for follow-ups.

Exclusion Criteria

Patients actively involved in workman's compensation cases

I have had surgery on the outer side of my elbow.

I have a condition like rheumatoid arthritis, psoriatic arthritis, or lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single application of Connective Tissue Allograft (CTA) or standard corticosteroid injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, range of motion, and grip strength

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Celestone
• CTM

Trial Overview The study aims to assess the effectiveness of a single application of CTM's human Connective Tissue Allograft (CTA) compared to Celestone in treating Tennis Elbow. The CTA involves using processed human placental tissue intended to repair or replace damaged connective tissue.

How Is the Trial Designed?

Group I: Test CTM Injection Experimental Treatment 1 Intervention

Group 2 Test Group: CTM injection: 1cc of CTM Boost will be diluted with 1 cc of 1% lidocaine and injected at the ECRB origin at area of maximal pain when palpated. CTM Boost is a connective tissue matrix suspended in saline. (injection will need to be with a 23 gauge needle and 3 cc syringe)

Group II: Standard of Care Steroid Injection Active Control 1 Intervention

Group 1 Control Group: standard corticosteroid injection: 1cc of celestone (6mg) diluted with 1 cc of 1% lidocaine and inject at the ECRB origin at area of maximal pain when palpated.

Celestone is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Celestone for:

• Preterm labor
• Respiratory distress syndrome prevention

Approved in United States as Betamethasone for:

• Preterm labor
• Respiratory distress syndrome prevention

Approved in European Union as Betamethasone for:

• Preterm labor
• Respiratory distress syndrome prevention

Who Is Running the Clinical Trial?

Indiana Hand to Shoulder Center

Lead Sponsor

Trials

9

Recruited

320+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+

Published Research Related to This Trial

A 36-year-old man developed HLA-B27-associated reactive arthritis within 24 hours of receiving a Wharton's jelly stem cell injection for low back pain, indicating potential risks associated with these treatments.

This case underscores the need for caution regarding the use of allogenic gestational tissue-derived products, as they may pose unknown dangers and require further study and regulation to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of HLA-B27-Associated Reactive Arthritis After a Wharton's Jelly "Stem Cell" Injection. Madhoun, H., Landry, K., Baria, MR.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06171555/efficacy-of-ctm-for-tennis-elbow

Efficacy of CTM for Tennis ELbow | Clinical Research Trial ... The study data suggest that patients without resolution after 6 months of onset may have a prolonged disease course and may need surgical ...

2. clinconnect.io clinconnect.io/trials/NCT06171555

Efficacy of CTM for Tennis ELbow (NCT06171555) The main goal is to see if CTM reduces elbow pain at 6 months, measured by the Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale. Researchers will ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7222600/

Management of Lateral Epicondylitis: A Narrative Literature ... This article presents a landscape of emerging evidence on lateral epicondylitis and focuses on the pathogenesis, diagnosis, and management.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06160427

NCT06160427 | Connective Tissue Matrix for Rotator Cuff ... The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff ...

5. biolscigroup.us biolscigroup.us/articles/JBM-6-130.pdf

Flowable placental connective tissue matrices for tendon repair FP-CTMs can enhance tendon repair by providing a three-dimensional extracellular matrix for cellular attachment and proliferation while ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9294091/

A decellularized flowable placental connective tissue ... Results from the present report demonstrate that I-CTM interacted more favorably with human tenocytes in vitro, compared with A-CTM and B-CTM.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06712290

Connective Tissue Matrix Compared to Steroid Injections ... The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix ...

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06171555/

Trial | NCT06171555 In this study, the objective is to evaluate the effectiveness of a single application of human Connective Tissue Allograft (CTA) as a treatment of LET. CTM ...