A Pilot study to Evaluate the Efficacy and Safety of Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment for the Patients with articular cartilage injury of the knee

A Pilot study to Evaluate the Efficacy and Safety of Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment for the Patients with articular cartilage injury of the knee: A Single center, Single-arm, Prospective, investigator-initiated Pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005566

Enrollment

Registered

2020-11-03

Start date

2020-11-09

Completion date

Unknown

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment with Microfracture Surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 65 2) Patients requiring Microfracture Surgery with articular cartilage lesions in the knee joint, and those with a Modified Outerbridge classification of Grade 3 or 4 3) Those whose joint cartilage lesions are 3cm2 or more in size 4) Those who participate in the clinical trial, observe treatment and procedures, and are willing to visit the hospital for all observational evaluation 5) A person who voluntarily signs a written consent after hearing the explanation of the purpose and method of this clinical trial

Exclusion criteria

Exclusion criteria: 1) Those who have already had the Microfracture Surgery or treatment at the treatment site 2) Those with a Body Mass Index (BMI) of higher than 35 3) Those who are pregnant or nursing, or who are of childbearing age, do not agree to maintain contraception during the clinical period * Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives installed, etc. 4) Those who are expected to increase bleeding because they cannot stop taking antithrombotic drugs or anticoagulants before surgery 5) Those with malignant tumors or history of malignant tumors within 5 years 6) Those with diabetes with severe complications 7) Those who are judged that the dawn is short (terminal patient) 8) Those who cannot understand the purpose and method of the clinical trial 9) Those who participated in other medical device intervention clinical trials within 6 months before participating in this study (in the case of drug intervention clinical trials, those who participated within 30 days) 10) Others, those who are judged to be difficult to conduct this clinical trial by Investigator

Design outcomes

Primary

Measure	Time frame
Change of Modified Outerbridge classification with MRI	—

Secondary

Measure	Time frame
Change of Modified Outerbridge classification with MRI;Change of VAS;Change of WOMAC;Change of Lysholm Score;Change of KL grade with X-ray	—

Countries

Korea, Republic of

Contacts

Public ContactJoon Ho Wang

Samsung Medical Center

Outcome results