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Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

S

Shandong University

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

Procedure: abdominal liposuction
Drug: Autologous adipose-derived mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03956719
2019042

Details and patient eligibility

About

The purpose of this study is to explore the efficacy and safety of autologous adipose mesenchymal stem cells in the treatment of early knee arthritis. Investigator believes that autologous adipose mesenchymal stem cells can relieve pain, improve knee function, promote knee cartilage regeneration and improve life satisfaction of patients.

Full description

Investigators extracted abdominal fat from eight patients, extracted autologous adipose mesenchymal stem cells and injected them into the knee joint of the patients. The data were followed up regularly after operation and compared with those before operation.

Enrollment

8 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 18-65 years, male and female, patient can tolerate surgery;
  • Clinical diagnosis of early stage degenerative arthritis by Radiographic Criteria and physical examination;
  • Obviously extra-articular malformation;
  • Course of disease ≥ six months;
  • No medication for knee osteoarthritis in the past three months
  • 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

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Autologous adipose-derived mesenchymal stem cells
Experimental group
Description:
Patients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells
Treatment:
Drug: Autologous adipose-derived mesenchymal stem cells
Procedure: abdominal liposuction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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