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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Cartilage Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Autologous Adipose-derived Mesenchymal Stem Cell Gel

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

Group Type EXPERIMENTAL

Autologous Adipose-derived Mesenchymal Stem Cell Gel

Intervention Type OTHER

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

Extraction of abdominal fat

Intervention Type PROCEDURE

In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.

sodium hyaluronate

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

Group Type PLACEBO_COMPARATOR

Sodium Hyaluronate

Intervention Type DRUG

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

Interventions

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Autologous Adipose-derived Mesenchymal Stem Cell Gel

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

Intervention Type OTHER

Sodium Hyaluronate

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

Intervention Type DRUG

Extraction of abdominal fat

In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.

Intervention Type PROCEDURE

Other Intervention Names

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hyaluronic acid Fat extraction

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No