Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta‐analysis

Mohammed, Yasmine Adel; Farouk, Hossam Khaled; Gbreel, Mohamed Ibrahim; Ali, Abdelrahman Mahmoud; Salah, Ali Ashraf; Nourelden, Anas Zakarya; Gawad, Mohamed Mahmoud Abd-El

doi:10.1186/s13047-022-00575-y

Cited by 22 publications

(7 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Most frequently used placenta-derived treatments are cryopreserved preparations that contain living cells and growth factors, and dehydrated products that contain growth factors but not living cells . In a meta-analysis of 11 multicenter randomized clinical trials of 655 participants with noninfected, nonischemic diabetic foot ulcers, patients receiving placenta-derived products had a higher incidence of complete resolution of diabetic foot ulcer at 12 to 16 weeks than those with similar care and an alginate or foam control dressing (66.9% vs 34.1%; RR, 2.0; 95% CI, 1.67-2.39; P < .001) …”

Section: Managementmentioning

confidence: 99%

Diabetic Foot Ulcers

Armstrong

Tan

Boulton

et al. 2023

JAMA

304

View full text Add to dashboard Cite

ImportanceApproximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. These ulcers precede 80% of lower extremity amputations among people diagnosed with diabetes and are associated with an increased risk of death.ObservationsNeurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, and about 20% of moderate to severe infections lead to lower extremity amputations. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation. The mortality rate for people with diabetic foot ulcers is 231 deaths per 1000 person-years, compared with 182 deaths per 1000 person-years in people with diabetes without foot ulcers. People who are Black, Hispanic, or Native American and people with low socioeconomic status have higher rates of diabetic foot ulcer and subsequent amputation compared with White people. Classifying ulcers based on the degree of tissue loss, ischemia, and infection can help identify risk of limb-threatening disease. Several interventions reduce risk of ulcers compared with usual care, such as pressure-relieving footwear (13.3% vs 25.4%; relative risk, 0.49; 95% CI, 0.28-0.84), foot skin measurements with off-loading when hot spots (ie, greater than 2 °C difference between the affected foot and the unaffected foot) are found (18.7% vs 30.8%; relative risk, 0.51; 95% CI, 0.31-0.84), and treatment of preulcer signs. Surgical debridement, reducing pressure from weight bearing on the ulcer, and treating lower extremity ischemia and foot infection are first-line therapies for diabetic foot ulcers. Randomized clinical trials support treatments to accelerate wound healing and culture-directed oral antibiotics for localized osteomyelitis. Multidisciplinary care, typically consisting of podiatrists, infectious disease specialists, and vascular surgeons, in close collaboration with primary care clinicians, is associated with lower major amputation rates relative to usual care (3.2% vs 4.4%; odds ratio, 0.40; 95% CI, 0.32-0.51). Approximately 30% to 40% of diabetic foot ulcers heal at 12 weeks, and recurrence after healing is estimated to be 42% at 1 year and 65% at 5 years.Conclusions and RelevanceDiabetic foot ulcers affect approximately 18.6 million people worldwide each year and are associated with increased rates of amputation and death. Surgical debridement, reducing pressure from weight bearing, treating lower extremity ischemia and foot infection, and early referral for multidisciplinary care are first-line therapies for diabetic foot ulcers.

show abstract

Section: Managementmentioning

confidence: 99%

Diabetic Foot Ulcers

Armstrong

Tan

Boulton

et al. 2023

JAMA

304

View full text Add to dashboard Cite

show abstract

“…LifeCell is a product derived from AM and is available in various forms such as patches, solutions, and creams. It is widely and safely used in cases involving the healing of large and treatment-resistant wounds, such as diabetic foot ulcers, corneal ulcers, and tissue stimulation in other organs [12].…”

Section: Discussionmentioning

confidence: 99%

“…AlloGraft Amniotic Membrane has applications in the treatment of various conditions such as corneal ulcers, burn wounds, treatment-resistant wounds in patients with venous or chronic ulcers, mucosal ulcers, and more [11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Effect of an Amniotic Membrane Derived Bio-Nano Product (LifeCell) on Human Endometrial Cells Proliferation and Gene Expression: An in-vitro Study

Sene,

Zandieh,

Amiri

et al. 2023

Preprint

View full text Add to dashboard Cite

Background Successful assisted reproductive technology (ART) requires a receptive endometrium with appropriate thickness and the presence of specific cytokines, chemokines, and growth factors. Despite advancements in ART, the success rates remain suboptimal, particularly in individuals with thin endometrium resistant to treatment. Objective In this study, we evaluated the potential effects of LifeCell, a product of BioNano Technology, on the growth, development, and acceptance of endometrial cells. Method We cultured endometrial cells in a defined medium with different concentrations of LifeCell and examined cell growth, development, and the expression of genes involved in endometrial receptivity. Result Co-culture of primary human endometrial cells with 5% Life cell solution significantly stimulated the endometrial cell growth, development and receptivity genes expression. The expression levels of FGF2 and CSF in the 72 hours co-cultured were significantly increased compared with other groups (P <0.01). HOXA10 and LIF significantly increased in the 72 hours co-cultured compared with 24 hours co-cultured and control groups but had no significant level compared with 48 hours cocultured. HOXA10 significantly increased in the 48 hours cocultured compared with control group. IL-6 and Hb-EGF increased in the 48 hours co-cultured compared to other groups but had no significant level. VEGF increased in the treated groups compared to control but had no significant level. The expression of OPN, unlike the other genes, decreased in the treated group compared to the control, which was not significant. Conclusion These findings suggest that LifeCell may be a potential option for patients with treatment-resistant thin endometrium in cases of infertility.

show abstract

“…Te reduction in the mechanical characteristics of dHAM is a challenge in TERM. To explain, after cell removal, collagenase released from cell debris interacts with ECM proteins, leading to vast degradation that impairs biophysical features [34]. For a more detailed explanation, collagenase enzyme activity increases at the wound site.…”

Section: Introductionmentioning

confidence: 99%

Bilateral Crosslinking with Glutaraldehyde and 1-Ethyl-3-(3-Dimethylaminopropyl) Carbodiimide: An Optimization Strategy for the Application of Decellularized Human Amniotic Membrane in Tissue Engineering

Alibabaei-Omran,

Zabihi,

Seifalian

et al. 2024

Journal of Tissue Engineering and Regenerative Medicine

View full text Add to dashboard Cite

Introduction. The decellularized human amniotic membrane (dHAM) emerges as a viable 3D scaffold for organ repair and replacement using a tissue engineering strategy. Glutaraldehyde (GTA) and 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC) can increase the biomechanical properties of dHAM. However, the crosslinking process is associated with biochemical changes and residual toxic materials, dampening the biocompatibility of the dHAM. From a histologic point of view, each side of the amniotic membrane is biologically different. While the dHAM basement membrane side is rich in growth factors, the stromal side of the dHAM contains more connective tissue matrix (e.g., collagen fibers) which supports its biomechanical properties. Biocompatibility and biomechanical properties are two important challenges in the field of materials science. In this study, for the first time, the stromal and basement membrane side are cross-linked with GTA and EDC, respectively, to optimize the biocompatibility of the treated dHAM while sparing the GTA-mediated biomechanical improvements. Methods. Crosslinking was carried out on dHAM in three groups: EDC, GTA and bilateral treatment with EDC&GTA. Mechanical resistance, degradability, and crosslinking measurements were performed on treated dHAM. The viability of mesenchymal stem cells (MSCs) on the scaffolds was evaluated by the MTT assay. The expression levels of surface markers and images of the MSCs were thoroughly studied. Results. The results obtained showed that bilateral treatment of dHAM with EDC and GTA increased mechanical resistance. Similarly, the evaluation of surface markers revealed that bilaterally treated dHAM sustains the stemness and viability of MSCs at a level equal to that achieved with EDC alone. The SEM images indicated that the MSCs maintained adhesion on EDC&GTA-cross-linked dHAM. Conclusion. The current study explores a pioneering treatment of dHAM, a material long recognized for its regenerative properties, in a novel context. This research delves into the utilization of dHAM cross-linked with EDC&GTA, demonstrating its optimized efficacy in tissue engineering. The enhanced crosslinking technique significantly alters the membrane’s properties, amplifying its durability and therapeutic potential. In this novel bilateral treatment strategy (EDC and GTA), improving mechanical properties by GTA on the stromal surface and maintaining the biocompatibility of EDC on the side of the basement membrane of dHAM had been attained together. By investigating the handling and impact of this cross-linked membrane, this study unveils a new approach in leveraging a well-known material through an innovative process, revolutionizing its application in wound care.

show abstract

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta‐analysis

Cited by 22 publications

References 42 publications

Diabetic Foot Ulcers

Diabetic Foot Ulcers

Evaluation of the Effect of an Amniotic Membrane Derived Bio-Nano Product (LifeCell) on Human Endometrial Cells Proliferation and Gene Expression: An in-vitro Study

Bilateral Crosslinking with Glutaraldehyde and 1-Ethyl-3-(3-Dimethylaminopropyl) Carbodiimide: An Optimization Strategy for the Application of Decellularized Human Amniotic Membrane in Tissue Engineering

Contact Info

Product

Resources

About