A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis

Centeno, Christopher J.; Fausel, Zachary; Stemper, Ian; Azuike, Ugochi; Dodson, Ehren

doi:10.1155/2020/5962354

Cited by 29 publications

(47 citation statements)

References 61 publications

(59 reference statements)

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“…Outcomes of the 25 patients who had reached 1 year follow-up showed significant improvements in pain at 3 and 6 months, and functional improvements at 3 months with the majority of posttreatment MRI scan demonstrated decrease in tear size. No adverse outcomes were reported (489).…”

Section: Shouldermentioning

confidence: 94%

“…Those patients in the treated group without intact tendons had received the lowest number of applied MSCs. Centeno et al (489) published a midterm analysis of a randomized crossover trial comparing percutaneous BMC with platelet-product injection versus exercise alone treatment of partial or full nonretracted supraspinatus tears. Outcomes of the 25 patients who had reached 1 year follow-up showed significant improvements in pain at 3 and 6 months, and functional improvements at 3 months with the majority of posttreatment MRI scan demonstrated decrease in tear size.…”

Section: Shouldermentioning

confidence: 99%

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Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

Centeno¹

2020

Pain Phys

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Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. Objectives: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. Methods: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration’s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. Objectives: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around “minimal manipulation” and “homologous use” within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. Methods: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. Results/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption.

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Section: Shouldermentioning

confidence: 94%

Section: Shouldermentioning

confidence: 99%

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

Centeno¹

2020

Pain Phys

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“…In the first randomized controlled trial of BMAC and PRP injections for partial and full-thickness nonretracted supraspinatus tears in a nonsurgical setting, the combined biological therapy showed better outcomes in comparison to exercise therapy[ 71 ]. Patients reported a mean 89% improvement at 24 mo with sustained functional gains and pain reduction.…”

Section: Prp and Bmac Synergismmentioning

confidence: 99%

Platelet-rich plasma vs bone marrow aspirate concentrate: An overview of mechanisms of action and orthobiologic synergistic effects

Lana¹,

Fonseca²,

Macedo³

et al. 2021

WJSC

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The use of orthobiologics as a novel therapy for the treatment of numerous musculoskeletal disorders has increased considerably over the past decade. Currently, there are multiple alternatives available as suitable treatments; however, the use of autologous blood-derived products such as platelet-rich plasma (PRP), bone marrow aspirate (BMA) and BMA concentrate (BMAC), specifically, is expanding. Although many investigations attempted to demonstrate the effectiveness of these therapies, even with positive results, the literature lacks standardized protocols and overall accuracy in study designs, which leads to variance and difficulty in reproducibility of protocols. The efficacy of PRP for the treatment of cartilage, bone and muscle tissues is well known. Although BMAC has generated optimistic results for the same purposes, its applicability in clinical trials is still relatively recent when compared to PRP. Both products demonstrate the potential to set forth reparative processes, each in their own distinct mechanism. The combination of these biological products has been previously proposed, yet little is known about their synergism. Evidence indicates that growth factor, cytokine, and chemokine profiles seen in both PRP and BMAC vary but are likely to work synergistically to enhance musculoskeletal healing. BMAC products seem to work well without PRP; however, the addition of PRP to BMAC has been shown to act as a rich and natural source of culture medium for stem cells located either peripherally or in the bone marrow itself. Nevertheless, additional variables associated with the use of BMAC and PRP in orthopedics must be further evaluated in order to consolidate the efficacy of this therapeutic strategy.

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“…16 Moreover, in the latest guideline by the American Academy of Orthopaedic Surgeons (AAOS), 17 the routine use of PRP in the non-operative management of PTRCs is not recommended by limited quality and number of evidences. Nonetheless, several trials have reported the positive effects of PRP injection for PTRCs or rotator cuff tendinopathy, 18, 19 while no meta-analysis study yet. To our’ knowledge, this is the first meta-analysis study of randomized controlled clinical trials aiming at the effectiveness of PRP in PTRCs and rotator cuff tendinopathy.…”

Section: Introductionmentioning

confidence: 99%

Conservative treatment of partial-thickness rotator cuff tears and tendinopathy with platelet-rich plasma: a systematic review and meta-analysis

Xiang

Deng

Liu

et al. 2020

Preprint

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PurposeTo assess the effect of platelet-rich plasma (PRP) as a conservative therapy on individuals with partial-thickness rotator cuff tears (PTRCs) or tendinopathy in terms of pain, and function.MethodsA systematic review and meta-analysis of randomized controlled trials were conducted. Short-term (6±1 months) and long-term (≥1 year) outcomes were analysed, including the visual analogue scale (VAS), Constant-Murley score (CMS), Shoulder Pain and Disability Index (SPADI), as well as American Shoulder and Elbow Surgeons (ASES) score. The weighted mean difference (MD) with 95% confidence interval (CI) was used.ResultsTen studies were eligible in this review, nine studies with 561 patients were included in this meta-analysis. The meta-analysis showed statistically significant differences in the decrease in short-term VAS (MD=-1.56; 95% CI -2.82 to -0.30), and increase in CMS (MD=16.48; 95% CI 12.57 to 20.40), and SPADI (MD=-18.78 95% CI -36.55 to -1.02). Nonetheless, no long-term effect was observed on pain and function, except CMS (MD=24.30). The results of mean important differences (MIDs) reached the minimal clinically important differences, except ASES. For subgroup analysis, short-term VAS scores were decreased in PRP-treated patients with double centrifugation (MD=-1.99), single injection (MD=-0.71) and post-injection rehabilitation (MD=-1.59).ConclusionPRP-treated patients with PTRCs and rotator cuff tendinopathy demonstrated improvements in pain and function, although the effect may not last for a long time. Overall, our results suggest that PRP may have positive clinical outcomes, but limited data, and study heterogeneity hinder firm conclusions.

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A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis

Cited by 29 publications

References 61 publications

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

Platelet-rich plasma vs bone marrow aspirate concentrate: An overview of mechanisms of action and orthobiologic synergistic effects

Conservative treatment of partial-thickness rotator cuff tears and tendinopathy with platelet-rich plasma: a systematic review and meta-analysis

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