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

54 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment for tennis elbow?

Research suggests that placenta-derived tissues, which are rich in healing factors, have shown promise in repairing tendon injuries and are being explored for use in sports medicine. These tissues have been used successfully in other tendon-related conditions, indicating potential benefits for tennis elbow. ^{1 2 3 4 5}

Is placenta-derived tissue safe for use in humans?

Some studies suggest that placenta-derived tissue can be safe, as seen in knee osteoarthritis treatments with no reported adverse events. However, there are cases of infections and other complications, such as reactive arthritis, following injections of similar products, indicating potential risks. ^{1 4 5 6 7}

How is the treatment using placenta-derived tissue for tennis elbow different from other treatments?

This treatment is unique because it uses cells derived from the placenta, which are believed to help repair and regenerate tendon tissue, offering a novel approach compared to traditional treatments like corticosteroids or physical therapy. ^{1 2 3 4 8}

What is the purpose of this trial?

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 Biomedical markets and distributes decellularized particulate human placental connective-tissue matrix products, intended solely for homologous use to supplement or replace damaged or inadequate connective-tissue. These are structural tissue allografts processed according to the criteria contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act. Drug/Device Handling: If the research involves drugs or device, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Human Placenta-Derived Cells in a Preclinical Model of Tendon Injury. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Nonoperative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of Literature. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Placenta: Applications in Orthopaedic Sports Medicine. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Infectious Achilles Tendinitis After Local Injection of Human Placental Extracts: A Case Report. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Allogenic Umbilical Cord Tissue for Treatment of Knee Osteoarthritis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Induction of HLA-B27-Associated Reactive Arthritis After a Wharton's Jelly "Stem Cell" Injection. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Immunomodulatory placental-expanded, mesenchymal stromal cells improve muscle function following hip arthroplasty. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Operative Applications of Placental Tissue Matrix in Orthopaedic Sports Injuries: A Review of the Literature. [2019]