SVF Therapy for Human Knee Osteoarthritis

NCT ID: NCT05019378

Last Updated: 2021-08-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-19

Study Completion Date

2019-01-28

Brief Summary

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The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

Detailed Description

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Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous SVF treatment

Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint

Group Type EXPERIMENTAL

SVF treatment

Intervention Type PROCEDURE

autologous SVF (10E8 cells)

Placebo group

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SVF treatment

autologous SVF (10E8 cells)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Knee Osteoarthritis
* Articular cartilage defect grades I/II of both knee

Exclusion Criteria

* autoimmune or inflammatory arthritis
* serious medical disorders
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xin Xiao Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Lin Cai, MD

Role: STUDY_DIRECTOR

Wuhan University

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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Zhongnanzxx

Identifier Type: -

Identifier Source: org_study_id

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