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临床试验/NCT05915962
NCT05915962已完成不适用

Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Microbiological sterility of nanofat autografts

研究概览

简要总结

Rhizarthrosis (trapeziometacarpal osteoarthritis) is the most common primary osteoarthritis of the hand, and a source of major functional impact, as it affects the thumb. Non-surgical therapeutic means are currently limited to wearing an immobilization splint, analgesics and oral non-steroidal anti-inflammatory drugs. These symptomatic treatments are of limited effectiveness and do not prevent from progression of the osteoarthritis disease. The most effective treatments currently recognized are surgical, but they also have their limits.

Cell therapy is considered as a promising approach to treat tissue damage including osteoarthritis. Mesenchymal stromal cells are excellent candidates for achieving this type of result, because they can differentiate into the different tissues from the mesoderm (cartilage, bone, muscle, tendons, fat, dermis, conjunctive matrix, etc.). In addition, unlike cells from the embryonic cord, the risk of teratoma or tumor does not exist.

Mesenchymal stem cells have regenerative and immunomodulatory properties but the methods of collection, preparation, combination with substances such as hyaluronic acid, or PRP, or platelet concentrates, will obviously influence the effectiveness of the results. .

Nanofat autografts are obtained in a simple way, in a closed circuit, preserving the stromal mesenchymal cells in large numbers with a minimum impact on the cellular elements. The preparation remains simple and inexpensive, but it is nevertheless necessary to characterize these emulsified preparations biologically before using them as cell therapy.

The main objective of this study is to characterize a nanofat autograft on a biological level.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Volunteers, men or women, aged at least 20 to 75 years old.
  • •BMI ≥ 20 Kg/m² (in order to have adipose tissue in quantity sufficient)
  • •Volunteers who signed an informed consent
  • •Hemoglobinemia > 10g/dl
  • •Negative Beta-HCG assay
  • •Volunteers benefiting from or affiliated to a social security scheme

排除标准

  • •Thrombocytopenia < 150 G/L
  • •Thrombocytosis > 450 G/L
  • •Known thrombopathy
  • •APT Patient/Control ratio > 1.20
  • •Anemia < 10g/dl
  • •Taking antiplatelet, aspirin, anti vitamin K dating less than 15 days before inclusion
  • •Fever or recent infection (bacterial or viral) dating from less than a month
  • •Autoimmune diseases confirmed by questioning, or clinical and/or biological elements (inflammatory assessment: VS, CRP, fibrinogen) and may interfere with the quality of autograft
  • •Inflammatory arthritis
  • •Microcrystalline Arthritis
  • •Immunodeficiency
  • •Current or chronic infectious diseases (viral or bacterial) attested by clinical elements and/or biological (inflammatory assessment: ESR, CRP, Fibrinogen)
  • •Malignant tumor under treatment or history of malignant tumor
  • •BMI < 20 Kg/m²
  • •Contraindication to local anesthesia or surgery
  • •Pregnant or breastfeeding women
  • •Adults protected by law (under guardianship and guardianship)
  • •People participating simultaneously in another research involving the human person
  • •Persons staying in a health or social establishment
  • •People in an emergency situation
  • •Persons deprived of liberty
  • •Persons not covered by a social security scheme

研究组 & 干预措施

volunteer for an autograft

Experimental

Collecting and preparing a Nanofat-type autograft using a special kit.

干预措施: collecting a Nanofat-type microfat autograft (Procedure)

结局指标

主要结局

Microbiological sterility of nanofat autografts

时间窗: one month

expected specification: negative

Appearance of nanofat autografts

时间窗: one month

Expected specification: colorless to slightly yellow

Functionality of nanofat autografts

时间窗: one month

Expected specification: CFU-F \> 10 per 1000 nucleated cells

Flow cytometry count of the following cells : leukocytes, stromal celles and endothelial cells

时间窗: one month

* Leukocytes (CD45+): 15 to 55% * Stromal cells (CD45-CD34bright CD146-CD90+): 40 to 60% * Endothelial cells (CD34bright CD146+CD45-): 1 to 19%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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