PLATELET-RICH PLASMA AS A SAFE AND EFFECTIVE AUTOLOGOUS TREATMENT FOR CHRONIC WOUND HEALING. Solange VISCHER, Antoine TURZI.

PLATELET-RICH PLASMA AS A SAFE AND EFFECTIVE AUTOLOGOUS TREATMENT FOR CHRONIC WOUND HEALING

Solange VISCHER, Senior Scientific Advisor, Regen Lab SA.
Antoine TURZI CEO, Regen Lab SA.

Summary

Platelet-rich plasma (PRP) is an autologous biological drug prepared from the patient's own blood and used as a treatment for wound healing and other lesions on the same patient.

  • It is still considered by many to be an experimental treatment and is not covered by insurance, despite the fact that there is now a significant medical consensus among clinicians worldwide who have published studies on the safety and efficacy of using PRP for chronic wounds.
  • The United States has become a pioneer in this field, deciding in 2021 to cover autologous PRP gel treatments for chronic non-healing diabetic foot wounds.
  • Various recent meta-analyses, summarized here, have compiled and synthesized clinical studies carried out on chronic wound patients treated with PRP gels in comparison with standard therapy. These meta-analyses demonstrate the safety and efficacy of PRP gels for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers and pressure sores.
Keywords: chronic wounds, diabetic foot ulcer, venous ulcer, pressure sores, platelet-rich plasma, PRP, medical devices, regulations, MDR 2017/745, FDA, MDSAP, ISO13485

 

INTRODUCTION

In April 2021 in the United States, the Centers for Medicare & Medicaid Services published the National Coverage Determination (NCD 270.3) for coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds under section 1862 (a) (1) (A) of the Social Security Act.

  • A treatment duration of 20 weeks is covered when prepared by devices, such as RegenKit® Wound Gel-2, whose FDA-approved indications include the management of exudative skin wounds, such as diabetic ulcers.
  • Regen Lab, Switzerland has been ISO13485 certified since 2003 for the manufacture and international marketing of RegenKits.
  • In Europe, RegenKits have already obtained their CE certificate under MDR regulation 2017/745. In the USA, RegenLab® USA received its first FDA approval in May 2010 with RegenKit®.
  • THT®, is part of a family of medical devices manufactured in the United States since November 2021.

In accordance with MDSAP ISO-13485, RegenKits are produced in Europe and the USA to the highest quality management standards.

  • RegenKit® technology enables rapid, standardized preparation of PRP in a closed-circuit system. This PRP (RegenPRP) has demonstrated its safety, reliability and efficacy in over 300 scientific and clinical publications in academic journals.
  • Autologous PRP is a suspension of platelets in plasma, prepared from the patient's own blood and used as a treatment for wound healing and other lesions on the same patient, minimizing the possibility of cross-reactivity and allergic reactions. Because PRP contains live, functional platelets, this biological product is different from other blood-derived autologous growth factor preparations such as clot extracts.
  • Similarly, frozen/thawed PRP is no longer considered true PRP, as most platelets do not survive this process [...1].

RegenKit® technologies, such as RegenKit® Wound Gel-2, produce PRP treatments from fresh, minimally manipulated blood to harness and maximize the patient's natural healing capacity.

  • Devices used to isolate PRP from patient blood fall under the definition of medical devices, and must therefore comply with current regulations.
  • Over the past 20 years, multiple technologies for bedside preparation of PRP have been approved by health authorities in every country.
    • In the European Union, they are governed by Regulation 2017/745 (MDR), which replaces Directive 93/42/EEC (MDD) from 2021.
    • In the USA, devices for the preparation of a PRP gel or membrane used as a biological wound dressing are regulated by the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). They carry the product code PMQ and follow section 864.9246 of the Code of Federal Regulation Title 21 (21 CFR 864.9245) for automated blood cell separators.

FDA-approved devices for wound care include :

  • Autologel System, Cytomedix, Inc, USA, (BK060007)
  • 3C Patch System, Reapplix Aps, Denmark, (BK140211, BK170002, BK200471)
  • RegenKit® Wound Gel-2, Regen Lab SA, Switzerland, (BK210661)
  • Another family of devices has been approved with the product code PMQ, but these devices (RD1 and RD2 Systems, RedDress Ltd, Israel, (BK170095, BK190349, BK200464, BK210570)) are not used to prepare a PRP gel but a whole blood clot combined with kaolin powder.

Compared with other devices designed to prepare PRP, RegenLab® devices produce PRP with a standardized composition.

  • The use of thixotropic separator gels with specific densities enables precise isolation of PRP from other blood components at cellular level.
  • This method of blood fractionation is highly reproducible because it is independent of the operator and the patient.
  • The resulting PRP, RegenPRP, is a leukocyte-poor PRP in which there is a specific depletion of pro-inflammatory neutrophil granulocytes.
  • The platelet recovery rate in RegenPRP is greater than 80 % without any specific loss of the largest and densest platelets, which are known to be the richest in growth factors [2].

This standardized PRP has proved effective in many different therapeutic areas.

  • For chronic wounds, RegenPRP has been successfully used in ten studies involving a total of 213 patients [3, 4, 5, 6, 7, 8, 9, 10, 11, 12].
  • All these studies have shown that the use of RegenPRP enables patients to achieve re-epithelialization and closure of chronic wounds such as diabetic foot ulcers, venous ulcers and other chronic wounds of various etiologies.

More specifically, with regard to diabetic foot ulcers, platelet gels prepared with RegenPRP have demonstrated their safety and efficacy in clinical evaluations.

  • RegenWound Gel (RWG) therapy was studied in a single-center, open-label, randomized, simultaneous controlled trial, in which ninety-one subjects were evaluated (47 in the RWG group, 44 in the control group).
    • Enrolled subjects were diagnosed with type 1 or type 2 diabetes, with one or more diabetic foot ulcers (DFUs), classified as grade 3A according to the University of All subjects received standard treatment (ST), including wound cleansing, removal of necrotic or infected tissue, management of wound infection, treatment of bone complications and appropriate discharge.
    • In addition to TS, the RWG group received an application of RegenPRP gel every 2-3 weeks when deemed necessary for up to 6 weeks.
    • At week 6, 55.3 % of subjects in the RWG group had their ulcer closed; while this value was 25.6 % for subjects in the control group.
    • At week 12 (i.e., the end of the study visit), the ulcer closure rate was 77.3 % in the RWG group, compared with 35.1 % in the control group [13].
  • Another clinical study that evaluated the safety and efficacy of RegenPRP autologous gel for UPD examined the treatment of patients with peripheral arterial disease (PAD) and concomitant diabetic foot ulcers, which are classified as grade 1C according to the University of Texas classification.
      • Thirty of the seventy-two subjects studied suffered from severe PAD, classified as critical limb ischemia.
      • By treating all patients with RegenPRP autologous gel, 100 % of limbs were saved in the 42 patients who had UPD with non-critical PAD, and 73 % of limbs were saved with the 30 patients who had UPD with critical PAD, for an average of 89 % of limb recovery [9].
  • Russo et al. carried out a study to determine the cost-effectiveness of RegenPRP gel treatment compared with standard treatment from the point of view of the French healthcare system [...14].
    • A cost-effectiveness analysis was carried out using a Markov decision model on a cohort of patients with chronic DFU (duration > 3 weeks) at high orthopedic risk, and with ulcers classified as 3A according to the University of the Netherlands classification. Efficacy results were reported in terms of quality-adjusted life years (QALYs).
    • Costs have been reported in euros (€) valued in 2019.
    • A micro-cost approach in parallel with a clinical study was used to assess resource utilization.
    • The incremental cost-effectiveness ratio of PRP treatment was - €613/QALY, which, being less than zero, indicates the predominance of PRP therapy.
    • They concluded that RegenPRP gel was a cost-effective or even economical alternative to standard care due to the improved rates of complete healing.

 

RECENT META-ANALYSES ON THE USE OF AUTOLOGOUS PRP FOR CHRONIC WOUNDS

Chronic wounds

Li et al (2023) conducted a study to compare PRP gels with normal saline dressings in the treatment of chronic wounds [15]. Three hundred and thirty (330) patients with chronic wounds, reported in eight randomized controlled trials (RCTs), were included in this study.

A total of 169 out of 330 (51.21 %) were treated with PRP gels and 161 out of 330 (48.79 %) were treated with normal saline dressings. The pooled results showed that the complete healing rate of the PRP group was significantly higher than that of the saline group at 8 weeks and 12 weeks, respectively.

In addition, there were no significant differences in wound infection rates and adverse events between the two groups.

Compared with normal saline dressings, PRP gel could effectively improve the prognosis of chronic wounds.

In addition, PRP gels were found to be safe, with no increase in wound infection rates or adverse events.

They concluded that PRP should be available for the treatment of chronic wounds.

Meznerics et al (2022) studied the therapeutic effects of platelet-rich plasma on the treatment of chronic wounds [16]. They identified 48 eligible RCTs comparing PRP with conventional ulcer treatment.

Thirty-three study groups from 29 RCTs with a total of 2,198 wounds showed that the chances of complete closure were significantly higher in the PRP group than in the control group (OR = 5.32; CI: 3.37; 8.40; I2 = 58 %). 

They concluded that PRP is a safe and effective modality for improving wound healing.

By implementing it in clinical practice, platelet-rich plasma could become a valuable and widely used tool, as it could not only improve patients' quality of life, but also reduce the healthcare burden associated with wound management.

Diabetic foot ulcers

Peng et al (2024) conducted a systematic review of RCTs comparing autologous PRP with conventional treatments for diabetic foot ulcers, in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines [17].

  • A total of 10 RCTs involving 550 patients (279 receiving PRP and 271 receiving conventional treatment) were included. In this study, PRP was found to significantly improve the cure rate (relative risk [RR] = 1.38, 95 % confidence interval [CI] 1.05 - 1.82, p = 0.02) and shorten the time to cure (mean difference [MD] = -23.23, 95 % CI -45.97 to -0.49, p = 0.05) of patients with DFU compared with conventional treatment.
  • Available data suggest that the incidence of adverse events was lower in the PRP group than in the conventional treatment group.
  • The authors concluded that, compared with conventional treatment, PRP effectively promoted healing in DFU patients, undoubtedly improving cure rates and healing times.

Platini et al (2024) conducted a systematic review of randomized controlled trials to assess the safety and efficacy of autologous PRP gel as a novel treatment for diabetic foot ulcers compared with standard therapy in adult patients.

  • Eight RCTs involving 598 patients were eligible for this analysis.
  • They concluded that, compared with standard care/conventional treatment, autologous PRP gel could significantly improve the healing rate, shorten healing time, shorten the length of hospital stay and reduce the amputation rate[.18].

Ruiz-Munoz et al (2024) conducted a systematic review of randomized controlled trials examining the effect of PRP versus conventional treatments on ulcer healing rates in diabetic patients.

  • Results were reported according to PRISMA guidelines.
  • Eleven articles were included in this review. The studies included a total of 418 individuals in the experimental group and 410 individuals in the control group, giving a total of 828 participants.
  • Study quality was assessed using the CASPe tool for critical reading of scientific evidence in the 11 clinical trials included in this review.
  • All studies passed the assessment, with scores ranging from 10 to 11 out of a total of 11 points, indicating high quality.
  • They found that PRP treatment significantly increased the ulcer healing rate compared to existing conventional treatments and concluded that PRP can be considered the first choice for treating ulcer closure and healing in diabetic patients [19].

Deng et al (2023) conducted a systematic review and meta-analysis of randomized controlled trials to investigate, evaluate and synthesize the scientific data on the safety and therapeutic efficacy of autologous PRP in the management of diabetic foot ulcers compared with conventional or any other alternative treatment [20].

  • A total of 22 articles were included. The selected trials involved a total of 1559 people with diabetic foot ulcers.
  • Of these participants, 785 were treated with PRP, while the remaining 774 were assigned to a control group.
  • The results of the meta-analysis indicate that autologous PRP has a significant positive effect on
    • healing rate (RR = 1.42, 95 CI % 1.30- 1.56, p < 0.001),
    • reduced healing time (DM = -3.13, 95% CI % -5.86 to -0.39, p<0.001),
    • accelerates ulcer surface reduction (DM = 1.02, 95 CI % 0.51-1.53, p < 0.001),
    • reduced amputation rate (RR = 0.35, 95 CI % 0.15-0.83, p < 0.001)
    • and did not increase the incidence of adverse events (RR = 0.96, 95% CI % 0.57-1.61, p > 0.05) compared to conventional treatment.
  • The results of this systematic review and meta-analysis indicate that the use of autologous PRP therapy is a viable and safe therapeutic approach for diabetic foot ulcers, as it effectively improves wound healing.

Gong et al (2023) carried out a meta-analysis to assess the effect of platelet-rich plasma versus standard management for the treatment of diabetic foot ulcers [21].

  • A systematic literature search, up to March 2022, was carried out on 19 studies including 1,435 subjects with diabetic foot ulcer wounds at baseline; 723 of these were treated with platelet-rich plasma and 712 received standard care.
  • They found that the use of autologous platelet-rich plasma resulted in significantly higher healing of diabetic foot ulcers compared with control treatment (P < 0.001).

OuYang et al (2023) evaluated the efficacy of PRP therapy for the treatment of diabetic foot ulcers in 20 controlled studies in accordance with PRISMA guidelines [22].

  • These studies included 1266 patients, 698 of whom were treated with PRP. The authors found that PRP significantly improved the cure rate (p<0.001) and shortened the healing time (p<0.001) of DFU patients compared to conventional treatment.

Su et al (2023) investigated the efficacy and safety of autologous PRP for the treatment of diabetic foot ulcers [23].

  • Seventeen studies involving a total of 1303 participants (649 randomized to the PRP group and 654 to a standard care group) met the eligibility criteria and were included in the study.
  • Compared with standard care, PRP appeared to enhance the rate of complete cure (odds ratio (OR): 2.11; 95-% confidence interval: 1.55-2.86).
  • PRP also appears to significantly shorten the time to complete healing (mean duration: -19.04 days; 95 CI % :-20,46–17,61).
  • There was no significant difference in adverse events.
  • The results of the sensitivity analyses were robust. They concluded that PRP is an effective and safe adjuvant treatment for diabetic foot ulcers.

Venous leg ulcers

Hu et al (2024) evaluated the efficacy and safety of PRP compared with conventional therapy for the treatment of venous ulcers.

  • A systematic review of four databases identified 16 randomized clinical trials involving 699 patients.
  • PRP significantly improved complete ulcer healing and increased the percentage of healed ulcer area by a mean difference of 47 %. In addition, PRP shortened the time to complete healing in an average of 3.25 months. PRP significantly reduced ulcer recurrence without increasing the risk of infection or irritant dermatitis.
  • They concluded that PRP is a viable and safe alternative for the treatment of venous ulcers, bringing significant improvements in healing outcomes and that integrating PRP into standard clinical procedures has the potential to improve patients' quality of life and reduce the burden of healthcare [?24].

Fang et al (2023) evaluated the clinical effects of platelet-rich plasma in the treatment of venous ulcers of the lower limbs using a meta-analysis method [...25].

  • A total of 294 patients with lower limb venous ulcers from 6 studies were included in the meta-analysis.
  • There were 148 patients in the experimental group treated with PRP versus 146 patients in the control group treated with conventional therapy.
  • The difference in cure rates between the experimental and control groups was statistically significant.
  • This study suggested that the application of PRP for venous ulcers of the lower limbs accelerates the wound healing process and improves wound healing rates.

Yammine et al (2022) conducted a systematic review to assess the efficacy of PRP compared with the standard of care commonly used to treat venous ulcers of the lower limbs [26].

  • Ten prospective studies (8 randomized) met the inclusion criteria and included 451 patients with 527 venous ulcers.
  • The results were as follows: a) the weighted odds ratio for the mean cure rate was 2.84 (95% CI % = 1.160 to 5.056, I2 = 41.4 %, p = 0.0004), b) the mean areas of healed ulcers were 79.2 ± 19 % for the PRP group and 51.7 ± 36 % for the control group (p = 0.007) in favor of the PRP group, and c) the weighted odds ratio for the rate of infection showed no significant difference between the two groups.
  • In addition, negative correlations were found between healing rate and duration of venous ulcers and initial ulcer size.
  • This meta-analysis demonstrated significant beneficial effects of autologous PRP compared to standard care on healing rate, surface area reduction and reduced healing time of venous ulcers. Infection and other complications were similar to standard care. They concluded that their analytical data support the use of PRP as a safe and effective treatment for venous ulcers.

" Pressure sores

Hu et al (2024) have explored the potential of PRP for pressure sores [...27].

  • Their meta-analysis of 9 RCTs, involving 511 patients with 523 pressure sores, revealed a significant improvement in healing rates (p < 0.000l).
  • Furthermore, the mean standard difference for the healed ulcer area favored the PRP group, reflecting an improvement of 1.38 cm2 (p = 0.02).
  • The reduction in pressure sore healing assessment scores in the PRP group surpassed that observed in the control group, demonstrating a standard mean difference of 1.69 (p = 0.01).
  • They concluded that PRP stands out as a promising and safe therapeutic approach for pressure sores.

CONCLUSION

Numerous clinical studies, systematic literature reviews and meta-analyses have demonstrated the value of PRP in the treatment of chronic wounds, including diabetic foot ulcers, venous leg ulcers and pressure sores.

Recent publications confirm the trend observed in previous meta-analyses and reviews, which all concluded that PRP improved the healing rate of chronic wounds and raised no safety concerns [28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38].

Chronic wounds are a silent epidemic affecting a large proportion of the world's population, especially vulnerable groups such as the elderly and the socio-economically disadvantaged.

In developed countries, it is estimated that 1 to 2 % of the population will suffer from a chronic wound during their lifetime [...39].

The dramatic increase in the ageing of the population will only increase these figures.

Platelet-rich plasma, when prepared from a patient's own blood using approved medical devices, has proved to be a safe and effective treatment with significant therapeutic and medico-economic benefits for the management of exudative skin wounds, such as diabetic ulcers and venous leg ulcers.

RegenKit® Wound Gel standardized technology is indicated for the treatment of chronic wounds, and facilitates the efficient and reproducible production of autologous PRP gel at the point of care, ensuring the highest level of quality and safety for the delivery of these effective and economical treatments to chronic wound patients.

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