RecruitingPhase 1ACTRN12610000985088

A phase 1 study to evaluate the potential role of mesenchymal stem cells in the treatment of chronic refractory tendinopathy

A phase 1 study to evaluate the potential role of mesenchymal stem cells in the treatment of chronic refractory Achilles tendinopathy


Sponsor

MMRI

Enrollment

9 participants

Start Date

Jun 1, 2011

Study Type

Interventional

Conditions

Summary

The purpose of this study is to assess if mesenchymal stem cells are a safe and effective therapeutic treatment option for people suffering from chronic disabling tendinopathy, who have no other effective treatment options


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting mesenchymal stem cells (special cells that can repair tissue) into a damaged Achilles tendon is safe and can reduce pain and improve function in people with long-standing Achilles tendinopathy who have not gotten better with other treatments. This is an early-phase safety study for people aged 40–75 who have had symptoms for at least 18 months. You may be eligible if: - You are between 40 and 75 years old - You have been diagnosed with mid-substance Achilles tendinopathy (confirmed by ultrasound) - You have had symptoms for at least 18 months - Your VISA-A function score is 55 or below - You have already tried a prescribed exercise rehabilitation program (at least 4 days per week for 8 weeks) without significant improvement - You are not of childbearing potential (females) You may NOT be eligible if: - Your Achilles problem is at the point of insertion into the heel bone (insertional tendinopathy) - You have a complete tendon tear - You have an inflammatory or rheumatological disorder - You have had Achilles surgery in the past 6 months - You have had a corticosteroid or platelet-rich plasma injection in the last 3 months - You have had cancer in the past 5 years (other than certain skin cancers) - You have HIV, hepatitis B or C, HTLV, or syphilis - You take anticoagulants (e.g., Warfarin) or anti-inflammatory medications (including aspirin) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Each patient will receive a single intratendon injection of unrelated, HLA-mismatched, placenta derived mesenchymal stem cells. There are 3 dosing arms in this study: low dose = 1x10^6, medium dose =

Each patient will receive a single intratendon injection of unrelated, HLA-mismatched, placenta derived mesenchymal stem cells. There are 3 dosing arms in this study: low dose = 1x10^6, medium dose = 4 x10^6 and high dose = 16 x10^6 cells.


Locations(1)

Australia

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ACTRN12610000985088