Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers

Farivar, Behzad S.; Toursavadkohi, Shahab; Monahan, Thomas S.; Sharma, Jashank; Ucuzian, Areck A.; Kundi, Rishi; Sarkar, Rajabrata; Lal, Brajesh K.

doi:10.1016/j.jvsv.2018.09.016

Cited by 19 publications

(20 citation statements)

References 11 publications

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“…Clinical outcomes of vCPM have been reported in multiple studies for wounds of various etiologies and locations. [12][13][14][15][16][17][18][19][20] In the present study using vLPM adjunct to SOC, we demonstrated similar closure rates to those rates previously shown in clinical studies with the cryopreserved formulation (Fig. 2).…”

Section: Discussionsupporting

confidence: 87%

“…13,15 In a prospective, single-arm study, 53.0% of patients achieved complete wound closure with vCPM plus SOC in the treatment of chronic venous leg ulcers (VLUs) that had previously failed 12 weeks of SOC. 17 All these studies show similar closure rates for wounds of various etiologies and locations that have been managed with either amnion-or chorion-derived vCPM adjunct to SOC.…”

Section: Introductionmentioning

confidence: 71%

“…12,14,16 The closure rate for VLUs of 47.4% is also similar to the 53.0% closure rate in a previous study utilizing vCPM in the treatment of chronic VLUs. 17 We further performed analyses of associations between study variables and clinical outcomes. Our results of the bivariate analysis revealed that wound closure depends on wound duration before treatment and time to closure is associated with a diabetes diagnosis, wound size, and wound duration.…”

Section: Discussionmentioning

confidence: 99%

“…[8][9][10][11] High closure rates for difficult-to-treat wounds of different etiologies and locations have been demonstrated in multiple vCPM clinical studies. [12][13][14][15][16][17][18][19][20] Two prospective studies, one utilizing amnionderived vCPM and one utilizing chorion-derived vCPM, demonstrated a 62% and 59.3% closure rate for chronic diabetic foot ulcers (DFUs) and chronic complex DFUs, respectively. 12,14 Results of these DFU prospective clinical trials are mirrored by reported DFU closure rates in real-world patients.…”

Section: Introductionmentioning

confidence: 99%

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Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Ananian¹,

Davis

Johnson

et al. 2019

Advances in Wound Care

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Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM). Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs). Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm 2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of £12 and >12 months duration, respectively. There were no AEs related to vLPM application. Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting. Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Ananian¹,

Davis

Johnson

et al. 2019

Advances in Wound Care

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“…As with other mesenchymal stem cells, PMSC surface markers include CD105, CD73, CD90, and CD44. PMSCs have been clinically investigated in the treatment of chronic venous ulcers with resultant higher quality tissue regeneration and repair[ 30 ].…”

Section: Resultsmentioning

confidence: 99%

Role of stem cell therapies in treating chronic wounds: A systematic review

Raghuram¹,

Yu²,

Lo³

et al. 2020

WJSC

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BACKGROUND The impairment of cutaneous wound healing results in chronic, non-healing wounds that are caused by altered wound environment oxygenation, tissue injury, and permissive microbial growth. Current modalities for the treatment of these wounds inadequately address the complex changes involved in chronic wound pathogenesis. Consequently, stem cell therapies have emerged as a potential therapeutic modality to promote cutaneous regeneration through trophic and paracrine activity. AIM To investigate current literature regarding use of stem cell therapies for the clinical treatment of chronic, non-healing wounds. METHODS PubMed, EMBASE, Cochrane Library, Web of Science, and Scopus were queried with combinations of the search terms “mesenchymal stem cells,” “adult stem cells,” “embryonic stem cells,” “erythroid precursor cells,” “stem cell therapies,” and “chronic wounds” in order to find relevant articles published between the years of 2000 and 2019 to review a 20-year experience. Reference lists from the articles were reviewed to identify additional pertinent articles. Retrieved manuscripts (reviews, case reports/series, retrospective/prospective studies, and clinical trials) were evaluated by the authors for their depiction of clinical stem cell therapy use. Data were extracted from the articles using a standardized collection tool. RESULTS A total of 43 articles describing the use of stem cell therapies for the treatment of chronic wounds were included in this review. While stem cell therapies have been explored in in vitro and in vivo applications in the past, recent efforts are geared towards assessing their clinical role. A review of the literature revealed that adipose-derived stem cells, bone marrow-derived stem cells, bone marrow-derived mononuclear cells, epidermally-derived mesenchymal stem cells, fibroblast stem cells, keratinocyte stem cells, placental mesenchymal stem cells, and umbilical cord mesenchymal stem cells have all been employed in the treatment of chronic wounds of various etiologies. Most recently, embryonic stem cells have emerged as a novel stem cell therapy with the capacity for multifaceted germ cell layer differentiation. With the capacity for self-renewal and differentiation, stem cells can enrich existing cell populations in chronic wounds in order to overcome barriers impeding the progression of wound healing. Further, stem cell therapies can be utilized to augment cell engraftment, signaling and activity, and resultant patient outcomes. CONCLUSION Assessing observed clinical outcomes, potential for stem cell use, and relevant therapeutic challenges allows wound care stakeholders to make informed decisions regarding optimal treatment approaches for their patients’ chronic wounds.

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Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products

Sharma

Zhao

2023

Adv Healthcare Materials

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Impaired wound healing after trauma, disorders, and surgeries impact millions of people globally every year. Dysregulation in orchestrated healing mechanisms and underlying medical complications make chronic wound management extremely challenging. Besides standard‐of‐care treatments including broad spectrum antibiotics and wound‐debridement, novel adjuvant therapies are clinically tested and commercialized. These include topical agents, skin substitutes, growth factor delivery, and stem cell therapies. With a goal to overcome factors playing pivotal role in delayed wound healing, researchers are exploring novel approaches to elicit desirable healing outcomes in chronic wounds. Although recent innovations in wound care products, therapies, and devices are extensively reviewed in past, a comprehensive review summarizing their clinical outcomes is surprisingly lacking. Herein, this work reviews the commercially available wound care products and their performance in clinical trials to provide a statistically comprehensive understanding of their safety and efficacy. The performance and suitability of various commercial wound care platforms, including xenogeneic and allogenic products, wound care devices, and novel biomaterials, are discussed for chronic wounds. The current clinical evaluation will provide a comprehensive understanding of the benefits and drawbacks of the most‐recent approaches and will enable researchers and healthcare providers to develop next‐generation technologies for chronic wound management.

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Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers

Cited by 19 publications

References 11 publications

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Role of stem cell therapies in treating chronic wounds: A systematic review

Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products

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