Dataset Information

Safety of autologous intramuscular platelet lysate injections in patients with critical limb ischaemia: A pilot, exploratory study.

ABSTRACT:

Background & objectives

Platelet concentrate contains a rich cocktail of growth factors that support growth and proliferation of cells. The primary goal of this study was to investigate the safety of platelet lysate (PL) in patients with critical limb ischaemia (CLI) not suitable for standard revascularization. Data on the preliminary efficacy are also presented.

Methods

Seven patients (18-70 yr) with CLI classified in the Rutherford grades 3-5, with history of intermittent claudication for more than eight weeks and were not suitable for standard revascularization, underwent autologous intramuscular injections of PL. These patients were examined physically alongside other parameters such as TcPO2, toe pressure, and ankle brachial index, at baseline and were followed up for 12 months.

Results

The procedure was well tolerated with no serious adverse or any adverse events reported during follow up. Although not the primary aim of this report, preliminary data showed significant clinical improvement in Rutherford stage, ankle-brachial index and toe pressure which persisted for a year.

Interpretation & conclusions

Intramuscular injection of PL was well tolerated with no major adverse events reported in our study participants. With the observed satisfactory safety data, preliminary efficacy data of PL should be further validated.

SUBMITTER: Sofia A

PROVIDER: S-EPMC9629534 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Safety of autologous intramuscular platelet lysate injections in patients with critical limb ischaemia: A pilot, exploratory study.

Sofia Adwan A Moaath AlSmady A Omar Al-Qatawneh AQ Rand Zaza Z Hanan Jafar J Amir Malkawi M Abdalla Awidi A

The Indian journal of medical research 20220201 2

<h4>Background & objectives</h4>Platelet concentrate contains a rich cocktail of growth factors that support growth and proliferation of cells. The primary goal of this study was to investigate the safety of platelet lysate (PL) in patients with critical limb ischaemia (CLI) not suitable for standard revascularization. Data on the preliminary efficacy are also presented.<h4>Methods</h4>Seven patients (18-70 yr) with CLI classified in the Rutherford grades 3-5, with history of intermittent claudi ...[more]

PMID: 35946204

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Project description:BackgroundPeripheral arterial disease is a major health problem, and in about 1% to 2% of patients the disease progresses to critical limb ischaemia (CLI). In a substantial number of patients with CLI, no effective treatment option other than amputation is available and around a quarter of these patients will require a major amputation during the following year. This is an update of the review first published in 2011.ObjectivesTo determine the effectiveness and safety of local intramuscular transplantation of autologous adult bone marrow mononuclear cells (BMMNCs) as a treatment for critical limb ischaemia (CLI).Search methodsFor this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched February 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1).Selection criteriaWe included all randomised controlled trials of CLI in which participants were randomly allocated to intramuscular administration of autologous adult BMMNCs or control (either no intervention or conventional conservative therapy). We excluded studies on patients with intermittent claudication.Data collection and analysisTwo authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. Disagreements were resolved by consensus or by the third author.Main resultsOnly two small studies, with a combined total of 57 participants, met our inclusion criteria and were finally included. They were classified as having a moderate risk of bias with unclear issues regarding their methods, and according to the GRADE approach, the overall quality of the evidence would be considered as moderate. In one study the effects of intramuscular injections of BMMNCs in the ischaemic lower limbs of patients with CLI were compared with control (standard conservative treatment). No deaths were reported and no significant difference was observed between the two groups for either pain (P = 0.37) or the ankle brachial index (ABI) parameter. However, the treatment group showed a significantly smaller proportion of participants undergoing amputation compared with the control group (P = 0.026).In the other study, following subcutaneous injections of granulocyte colony-stimulating factor (G-CSF) for five days, peripheral blood derived mononuclear cells were collected and then transplanted by intramuscular injections into ischaemic lower limbs. The effects were compared with daily intravenous prostaglandin E1 injections (control group). No deaths were reported. Pain reduction was greater in the treatment group than in the control group (P < 0.001) as was increase in ABI (mean increase 0.13 versus 0.02, P < 0.01). The treatment group experienced a statistically significant increase in pain-free walking distance (PFWD) compared with the control group (mean increase 306.4 m versus 78.6 m, P = 0.007). A smaller proportion of participants underwent amputation in the treatment group compared with the control group (0% versus 36%, P = 0.007).Authors' conclusionsThe data from the published trials suggest that there is insufficient evidence to support this treatment. These results were based on only two trials which had a very small number of participants. Therefore evidence from larger randomised controlled trials is needed in order to provide adequate statistical power to assess the role of intramuscular mononuclear cell implantation in patients with CLI.

Dataset Information

Safety of autologous intramuscular platelet lysate injections in patients with critical limb ischaemia: A pilot, exploratory study.

Background & objectives

Methods

Results

Interpretation & conclusions

Publications

Safety of autologous intramuscular platelet lysate injections in patients with critical limb ischaemia: A pilot, exploratory study.

Similar Datasets

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