Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury

Shandong University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cartilage Degeneration; Knee Osteoarthritis

Treatments: Procedure: Extraction of abdominal fat; Other: Autologous Adipose-derived Mesenchymal Stem Cell Gel; Drug: Sodium Hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT03955497

2018023

Details and patient eligibility

About

This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.

Full description

The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-65 years, male and female, patient can tolerate surgery;
• Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
• Obviously extra-articular malformation;
• Good contralateral interventricular cartilage;
• Course of disease ≥ six months;
• There was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer;
• Subjects who understand and sign the consent form for this study.

Exclusion criteria

• Acute joint injury;
• Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
• Cancer patients;
• Women who are pregnant or breast feeding,or allergic constitution patient;
• Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
• Receive other open surgery related to knee operation within 6 months;
• Participation in another clinical trial;
• Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Autologous Adipose-derived Mesenchymal Stem Cell Gel

Experimental group

Description:

The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.

Treatment:

Other: Autologous Adipose-derived Mesenchymal Stem Cell Gel

Procedure: Extraction of abdominal fat

sodium hyaluronate

Placebo Comparator group

Description:

The control group received intra-articular injection of sodium hyaluronate one month after operation.

Treatment:

Drug: Sodium Hyaluronate