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A Clinical Trial for Safety and Efficacy of Human Umbilical Cord Blood - Derived Mesenchymal Stem Cells To Enhance Tendon Graft Healing in Anterior Cruciate Ligament Reconstruction With 2 Years Follow-Up
ESSKA Academy. Moon S. May 12, 2018; 218162; FP49-838
Sang Won Moon
Sang Won Moon
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Abstract
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Objectives: Mesenchymal stem cells (MSCs) showed therapeutic potential to enhance tendon graft healing in anterior cruciate ligament (ACL) reconstruction of animal study. Allogenic hUCB-MSCs may be used safely without treatment related adverse event, and prevent tunnel enlargement and improve clinical results in human ACL reconstruction.

Methods: Thirty patients, who underwent ACL reconstruction, were enrolled consecutively. The patients were divided 3 groups by randomization. For group A, ACL reconstruction surgery without additional treatment was performed as a negative control group. For group B, hUSB_MSCs and hyaluronic acids mixture were applied on tendon-bone interface of femoral and tibial tunnels during ACL reconstruction surgery. For group C, only hyaluronic acids were applied as a positive control group. Finally, 27 patients were analyzed after exclusion of three patients (re-rupture 1, death 1, follow-up loss 1). Incidence of treatment-related adverse event (infection, tumor formation), clinical outcomes including second-look arthroscopic finding, and amount of tunnel enlargement were evaluated.

Results: There was no treatment-related adverse event in treatment groups. There was no significant difference between the groups in clinical outcomes such as KT-2000 (p=0.793), pivot shift test (p=0.9245), IKDC subjective score (p=0.8227), Tegner activity level (p=0.9927) and second-look arthroscopic findings (synovial coverage of the graft, p=0.613, condition of the graft, p=0.5606). Tunnel enlargement of stem cell treatment group (579.74 ± 389.85 mm3) is not different from negative (641.97 ± 455.84 mm3) and positive control (421.96 ± 274.83 mm3) groups (p=0.6468).

Conclusions: Allogenic hUCB-MSCs were used safely without treatment related adverse event for 2 years follow-up. But, it failed to show clinical advantage such as decrease of knee laxity or improvement of clinical outcomes, and prevention of tunnel enlargement postoperatively.

Keywords:
Anterior cruciate ligament (ACL); Human umbilical cord blood - derived mesenchymal stem cell (hUCB-MSC); Stem cell; tendon graft healing; healing; randomized control trial (RCT)
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