[Medipana News 2019-12-5]
Study on the Efficacy of Autologous Bone Marrow-Derived Stem Cell Injections for Intractable Plantar Fasciitis
A Prospective, Randomized, Controlled Trial
Dong-Woo Shim, Department of Orthopedics, International St. Mary’s Hospital
Plantar fasciitis is a common, chronic foot condition that can lead to functional impairment. While the exact pathophysiology remains unknown, increased proximal fascial thickness, decreased blood flow, peritendon inflammation, and changes in pain receptors are believed to contribute to the symptoms. Pain is typically most severe with the first step in the morning, persisting or improving throughout the day, and worsening during daily activities. Bilateral plantar fasciitis occurs in 10% of patients, and more than 80% improve within one year with conservative treatment alone. Given this natural course, most patients improve without specific treatment. However, approximately 10% of patients who receive conservative treatment experience persistent pain. Therefore, patients complaining of hindfoot pain are treated with stretching exercises, shoe correction, steroid injections, autologous blood injections, extracorporeal shock wave therapy, nighttime orthotics, and non-inflammatory analgesics. If these conservative treatments fail to improve symptoms, surgical treatments such as plantar fascia release may be considered. However, the pros and cons of these treatments vary widely among authors.
Stem cell therapy has recently gained attention and has been proposed as a treatment option for osteochondral injuries of the talus. While clinical data are limited, Ambrosi et al. reported significant clinical improvement after administering autologous adipose-derived stem cells to four patients with talar osteochondral injuries. However, there are no studies on the efficacy of stem cell therapy for tendon inflammation, such as plantar fasciitis. This study aims to report on the differences in treatment outcomes between stem cell therapy and other treatments for patients with refractory plantar fasciitis, in whom symptoms persist despite appropriate conservative treatment. 1. If you agree to participate in the study, blood tests, an electrocardiogram, and a chest X-ray will be performed to assess your overall health, similar to traditional surgical preparation.
- After general or lower body anesthesia, a bone marrow collection syringe will be inserted into the autologous iliac bone (hip bone). Approximately 30 ml of bone marrow will be collected and separated to extract approximately 5 ml of mononuclear cells. The investigator will randomly assign the plantar fascia to receive stem cell injection. To determine the histological characteristics of refractory plantar fasciitis before the procedure, a plantar fascia biopsy will be performed under local anesthesia, using ultrasound guidance, at the proximal attachment of the plantar fascia on both sides. Under the guidance of the principal investigator, approximately 5 ml of stem cell mononuclear cells will be administered to the experimental group, and approximately 5 ml of 0.9% saline to the contralateral group.
(※The procedure is performed in the operating room, and a blinding procedure is performed to prevent observation of the procedure progressing below the pelvis through a curtain placed over the upper body.) - Clinical observations will be conducted at 6 weeks, 3 months, 6 months, and 1 year after the procedure. A repeat ultrasound-guided plantar fascia biopsy will be performed at 1 year.
This study will involve a total of 18 participants. The expected follow-up period is 12 months. Four hospital visits will be required during this period: at 6 weeks, 3 months, 6 months, and 1 year.
The medications and devices used in this clinical study are supplied by Miracell Co., Ltd., and are used to extract autologous bone marrow-derived stem cells for the purpose of regenerating cartilage in patients with cartilage damage. This device is a medical device approved by the Ministry of Food and Drug Safety for the treatment of cartilage damage. This clinical study will evaluate its effectiveness in treating inflammation in tendons and tendon tissues, including the fascia.
For inquiries, contact: Dong-Woo Shim, Department of Orthopedics, International St. Mary’s Hospital
Email: dcastle@hanmail.net
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