Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.
Adipose Tissue
/ cytology
Adult
Aged
Female
Follow-Up Studies
Humans
Male
Middle Aged
Pilot Projects
Point-of-Care Systems
Prospective Studies
Regeneration
/ physiology
Rotator Cuff Injuries
/ diagnostic imaging
Single-Blind Method
Stem Cell Transplantation
/ methods
Transplantation, Autologous
/ methods
Treatment Outcome
Adipose-derived regenerative cells (ADRCs)
Partial rotator cuff tear
Point of care treatment
Safety
Shoulder disease
Stem cells
Stromal vascular fraction
Journal
Journal of orthopaedic surgery and research
ISSN: 1749-799X
Titre abrégé: J Orthop Surg Res
Pays: England
ID NLM: 101265112
Informations de publication
Date de publication:
30 Mar 2020
30 Mar 2020
Historique:
received:
07
01
2020
accepted:
12
03
2020
entrez:
3
4
2020
pubmed:
3
4
2020
medline:
8
1
2021
Statut:
epublish
Résumé
This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection. Subjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 10 No severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05). This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing. Clinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136. Level I; prospective, randomized, controlled trial.
Sections du résumé
BACKGROUND
BACKGROUND
This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection.
METHODS
METHODS
Subjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 10
RESULTS
RESULTS
No severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05).
DISCUSSION
CONCLUSIONS
This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136.
LEVEL OF EVIDENCE
METHODS
Level I; prospective, randomized, controlled trial.
Identifiants
pubmed: 32238172
doi: 10.1186/s13018-020-01631-8
pii: 10.1186/s13018-020-01631-8
pmc: PMC7110715
doi:
Banques de données
ClinicalTrials.gov
['NCT02918136']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
122Subventions
Organisme : Sanford Health
ID : N/A
Organisme : InGeneron, Inc.
ID : N/A
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