Effect of Autologous Expanded Bone Marrow Mesenchymal Stem Cells or Leukocyte-Poor Platelet-Rich Plasma in Chronic Patellar Tendinopathy (With Gap >3 mm): Preliminary Outcomes After 6 Months of a Double-Blind, Randomized, Prospective Study.


Journal

The American journal of sports medicine
ISSN: 1552-3365
Titre abrégé: Am J Sports Med
Pays: United States
ID NLM: 7609541

Informations de publication

Date de publication:
05 2021
Historique:
pubmed: 31 3 2021
medline: 25 5 2021
entrez: 30 3 2021
Statut: ppublish

Résumé

Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy. Randomized controlled trial; Level of evidence, 2. A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 10 The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities ( Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP. 2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier).

Sections du résumé

BACKGROUND
Patellar tendinopathy is common. The success of traditional management, including isometric or eccentric exercises combined with shockwave therapy and even surgery, is limited. Therefore, it is important to determine whether biological treatments such as ultrasound-guided intratendinous and peritendinous injections of autologous expanded bone marrow mesenchymal stem cells (BM-MSCs) or leukocyte-poor platelet-rich plasma (Lp-PRP) improve clinical outcomes in athletic patients with patellar tendinopathy.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
A prospective, double-blinded, randomized, 2-arm parallel group, active controlled, phase 1/2 single-center clinical study was performed in patients who had proximal patellar tendinopathy with a lesion >3 mm. A total of 20 participants (age 18-48 years) with pain for >4 months (mean, 23.6 months) and unresponsive to nonoperative treatments were randomized into 2 groups. Of these, 10 participants were treated with BM-MSC (20 × 10
RESULTS
The average VAS scores improved in both groups at all time points, and there was a significant reduction in pain during sporting activities (
CONCLUSION
Treatment with BM-MSC or Lp-PRP in combination with rehabilitation in chronic patellar tendinopathy is effective in reducing pain and improving activity levels in active participants. Participants who received BM-MSC treatment demonstrated greater improvement in tendon structure compared with those who received Lp-PRP.
REGISTRATION
2016-001262-28 (EudraCT identifier); NCT03454737 (ClinicalTrials.gov identifier).

Identifiants

pubmed: 33783227
doi: 10.1177/0363546521998725
doi:

Banques de données

ClinicalTrials.gov
['NCT03454737']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1492-1504

Auteurs

Gil Rodas (G)

Medical Department FC Barcelona, Barcelona, Spain.
Sports Medicine Unit, Clínic Hospital and Sant Joan de Déu Hospital, Barcelona, Spain.

Robert Soler-Rich (R)

Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon, Barcelona, Spain.

Joan Rius-Tarruella (J)

Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon, Barcelona, Spain.

Xavier Alomar (X)

Diagnóstico por la Imagen, Clínica Creu Blanca, Barcelona, Spain.

Ramon Balius (R)

Consell Català de l'Esport, Generalitat de Catalunya, Barcelona, Spain.

Lluís Orozco (L)

Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon, Barcelona, Spain.

Lorenzo Masci (L)

Institute of Sports Exercise and Health (ISEH), London, UK.

Nicola Maffulli (N)

Department of Musculoskeletal Disorders, University of Salerno School of Medicine, Surgery and Dentistry, Salerno, Italy.
Centre for Sports and Exercise Medicine, Queen Mary University of London, London, UK.
School of Pharmacy and Bioengineering, Keele University School of Medicine, Staffordshire, UK.

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Classifications MeSH