NCT02142842

Brief Summary

Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Apr 2013

Typical duration for phase_1 knee-osteoarthritis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

May 16, 2014

Last Update Submit

January 20, 2016

Conditions

Knee Osteoarthritis

Keywords

Adipose stem cellPlatelet rich plasmaKnee OsteoarthritisInjured cartilage

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    6 months

Secondary Outcomes (3)

  • Change from the baseline pain score (VAS) at 6 months

    6 months, 12 months, 18 months

  • Change from baseline Lysholm score at 6 months

    6 months, 12 months, 18 months

  • Change from baseline MRI assessment

    12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control.

Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma

Interventions

Autologous adipose tissue stromal vascular fraction and platelet rich plasmaBIOLOGICAL
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years and ability to understand the planned treatment.
  • Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity
  • Ability and willingness to undergo liposuction

You may not qualify if:

  • Pregnant women or cognitively impaired adults.
  • Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
  • Inflammatory or postinfectious arthritis.
  • More than 5 degrees of varus or valgus deformity.
  • Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
  • Intraarticular corticosteroid injection within the previous 3 months.
  • A major neurologic deficit.
  • Serious medical illness with a life expectancy of less than 1 year.
  • Prior admission for substance abuse
  • Body Mass Index (BMI) of 40 kg/m2 or greater
  • Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
  • In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

115 Hospital, Ho Chi Minh city

Ho Chi Minh City, Vietnam

Location

Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh

Ho Chi Minh City, Vietnam

Location

Van Hanh Hospital, Ho Chi Minh city, VN

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Phuc V Pham, PhD

    Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN

    STUDY DIRECTOR

  • Phuong TB Le, MSc, MD

    Van Hanh Hospital, Ho Chi Minh city, VN

    PRINCIPAL INVESTIGATOR

  • Phu D Nguyen, PhD, MD

    115 Hospital, HCM

    PRINCIPAL INVESTIGATOR

  • Ho H La, MD

    Van Hanh Hospital, Ho Chi Minh city, VN

    PRINCIPAL INVESTIGATOR

  • Tung DX Tran, MSc, MD

    Van Hanh Hospital, Ho Chi Minh city, VN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory of Stem Cell Research and Apllication

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 20, 2014

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

VN(3)