The Composition of Adipose-Derived Regenerative Cells Isolated from Lipoaspirate Using a Point of Care System Does Not Depend on the Subject’s Individual Age, Sex, Body Mass Index and Ethnicity

Schmitz, Christoph; Alt, Christopher; Azares, Alon R.; Pearce, David A.; Facile, Tiffany R.; Furia, John P.; Maffulli, Nicola; Huang, Claire Y.‐H.; Alt, Eckhard

doi:10.3390/cells12010030

Cited by 8 publications

(14 citation statements)

References 64 publications

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“…Adipose tissue-derived stem and regenerative cells can be isolated and administered in large numbers at the "point of care" without cell expansion/culturing [23]. These nonengineered cells also lead to high clinical safety and efficacy [24,25,26] Our data suggest an initial anti-inflammatory impact of the cells used. We also clinically observed an acute anti-inflammatory effect of the ADSCs, evidenced by the first clinical improvement often seen already 48 hours after treatment.…”

Section: Discussionmentioning

confidence: 78%

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Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Rothoerl¹,

Tomelden²,

Alt³

2023

Preprint

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Background: Chronic Back Pain due to Facet Joint Syndrome is a common and debilitating con-dition. Advances in regenerative medicine have shown that Autologous Unmodified Adipose Tissue-Derived Regenerative Cells (ADRC) provide several beneficial effects [1,2]. These regen-erative cells can differentiate into various tissues [3] and exhibit a strong anti-inflammatory po-tential. ADRCs can be obtained from a small amount of fatty tissue derived from the patient´s abdominal fat. Methods: We report long-term results of 37 patients (age 31-78 years, mean 62.5) suffering from “Facet Joint Syndrome” The pathology was confirmed by clinical, radiological examinations and fluoroscopically guided test injections. Then liposuction was performed. 50-100 cc of fat were harvested. To recover stem cells from adipose tissue, we use the CE-certified Transpose RT™ system from InGeneron GmbH. The cells were then injected under fluoroscopic control in the periarticular fat. Follow-up examinations were performed at one week 1 and 5 years. Results: Every patient reported improved VAS pain at any follow-up (1 week, 1, and 5 years) with ADRCs compared to the baseline. Conclusion: Our observational data indicate that facet joint syndrome patients treated with unmodified adipose tissue-derived regenerative cells experience improved quality of life in the long term.

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Section: Discussionmentioning

confidence: 78%

“…Consequently, local tissue damage can be treated by injecting stem cells at the site needing repair. Clinical applications have shown that tissue of all three germ lines can be treated with stem cells [2,25,26]. In degenerative diseases of joints, damage to functional tissue induces an inflammatory process, resulting in pain.…”

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Rothoerl¹,

Tomelden²,

Alt³

2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Adipose tissue-derived stem and regenerative cells can be isolated and administered in large numbers at the “point of care” without cell expansion/culturing [ 26 ]. These non-engineered cells also lead to high clinical safety and efficacy [ 20 , 21 , 27 ].…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, local tissue damage can be treated by injecting stem cells at the site needing repair. Clinical applications have shown that tissue of all three germ lines can be treated with stem cells [ 15 , 20 , 21 ]. In degenerative diseases of joints, damage to functional tissue induces an inflammatory process, resulting in pain.…”

Section: Introductionmentioning

confidence: 99%

Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Rothoerl

Tomelden

Alt

2023

JPM

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Background: Chronic back pain due to facet joint syndrome is a common and debilitating condition. Advances in regenerative medicine have shown that autologous unmodified adipose tissue-derived regenerative cells (ADRC) provide several beneficial effects. These regenerative cells can differentiate into various tissues and exhibit a strong anti-inflammatory potential. ADRCs can be obtained from a small amount of fatty tissue derived from the patient’s abdominal fat. Methods: We report long-term results of 37 patients (age 31–78 years, mean 62.5) suffering from “Facet Joint Syndrome” The pathology was confirmed by clinical, radiological examinations and fluoroscopically guided test injections. Then, liposuction was performed. An amount of 50–100 cc of fat was harvested. To recover stem cells from adipose tissue, we use the CE-certified Transpose RT™ system from InGeneron GmbH. The cells were then injected under fluoroscopic control in the periarticular fat. Follow-up examinations were performed at 1 week, 1 year, and 5 years. Results: Every patient reported improved VAS pain at any follow-up (1 week, 1 year, and 5 years) with ADRCs compared to the baseline. Conclusions: Our observational data indicate that facet joint syndrome patients treated with unmodified adipose tissue-derived regenerative cells experience improved the quality of life in the long term.

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“…In brief, all the subjects enrolled in the former study [12] suffered from a sPTRCT of the supraspinatus tendon at baseline, had not responded to physical therapy treatments for at least six weeks, and were randomly assigned to receive either a single injection of an average 11.4 × 10 6 UA-ADRCs (in 5 mL liquid; mean cell viability: 88%) (n=11; modified intention-to-treat (mITT) population) (hereafter: UA-ADRCs group) or a single injection of 80 mg of methylprednisolone (40 mg/mL; 2 mL) plus 3 mL of 0.25% bupivacaine (n=5 in the former study [12]; n=4 in the present study; mITT population) (hereafter: corticosteroid group). The UA-ADRCs were isolated from lipoaspirate using the Transpose RT system (InGeneron, Houston, TX, USA) [15,20]. One subject in the corticosteroid group experienced progression of sPTRCT into a symptomatic, full-thickness rotator cuff tear during the former study [12] and was therefore not enrolled in the present study.…”

Section: Methodsmentioning

confidence: 99%

Long-term safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells isolated at the point of care: 41 months follow-up of a prospective, randomized, controlled, first-in-human clinical trial

Lundeen¹,

Hurd²,

Hayes³

et al. 2022

Preprint

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Objective: Symptomatic, partial-thickness rotator cuff tears (sPTRCT) are problematic. Management of sPTRCT with fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and leads to improved shoulder function without adverse effects. This study tested the hypothesis that management of sPTRCT with injection of UA-ADRCs is safe and more effective than injection of corticosteroid even in the long run. Methods: Subjects who had completed a former randomized controlled trial were enrolled in the present study. At baseline these subjects had not responded to physical therapy treatments for at least six weeks, and were randomly assigned to receive respectively a single injection of an average 11.4 x 10^6 UA-ADRCs (n = 11) or a single injection of 80 mg of methylprednisolone (n = 5). Safety was assessed by rigorously documenting and evaluating treatment emergent adverse events. Efficacy was assessed using the ASES Total score, pain visual analogue scale (VAS) and RAND Short Form-36 Health Survey at 33.2 ± 1.0 (mean ± standard deviation) and 40.6 ± 1.9 months post-treatment. Proton density, fat-saturated, T2-weighted (PD FS T2), magnetic resonance imaging (MRI) of the index shoulder was performed at both study visits. Results: There were no greater risks connected with injection of UA-ADRCs than those connected with injection of corticosteroid. The subjects in the UA-ADRCs group showed statistically significantly higher mean ASES Total scores than the subjects in the corticosteroid group. Treatment outcome could not be assessed using measurements of tear volume on MRI scans. On the other hand, PD FS T2 MRI scans at six months post-treatment allowed to "watch the UA-ADRCs at work". There was no relationship between treatment outcome and baseline data, including those data characterizing UA-ADRCs that can be collected with a clinical test. Conclusions: The present study further supports treatment of sPTRCT with injection of UA-ADRCs. Trial registration: Clinicaltrials.govNCT04077190(September 4, 2019).

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The Composition of Adipose-Derived Regenerative Cells Isolated from Lipoaspirate Using a Point of Care System Does Not Depend on the Subject’s Individual Age, Sex, Body Mass Index and Ethnicity

Cited by 8 publications

References 64 publications

Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Safety and Efficacy of Autologous Stem Cell Treatment for Facetogenic Chronic Back Pain

Long-term safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells isolated at the point of care: 41 months follow-up of a prospective, randomized, controlled, first-in-human clinical trial

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