NCT02162693

Brief Summary

Current medication treatments for KOA aim to relieve inflammation and pain, but they do little to delay or reverse the disease progression and most medications have obvious side effects. When the conservative treatments are useless to patients and joint deformities and joint disfunction, the patients may require surgery. Although surgery of the joints can relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Nov 2013

Typical duration for phase_2 knee-osteoarthritis

Geographic Reach
1 country

2 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

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

March 19, 2014

Last Update Submit

November 14, 2017

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)

    12 months

Secondary Outcomes (1)

  • Recording of Adverse Events and Serious Adverse Events

    12 months

Study Arms (2)

Mesenchymal progenitor cells

EXPERIMENTAL

Administrated for intra-articular use of Mesenchymal progenitor cells

Biological: Mesenchymal progenitor cells

Sodium Hyaluronate

ACTIVE COMPARATOR

Administrated for intra-articular use of Sodium Hyaluronate.

Biological: Sodium Hyaluronate

Interventions

Mesenchymal progenitor cellsBIOLOGICAL

Administrated for intra-articular injection

Mesenchymal progenitor cells
Sodium HyaluronateBIOLOGICAL
Sodium Hyaluronate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is between 18-70 years of age, regardless of gender
  • The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
  • The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms

You may not qualify if:

  • The subject has an allergic history or is of an allergic constitution
  • The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
  • The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
  • The subject has severe infectious diseases or a malignant tumour
  • The subject has coagulation disorders
  • The subject has a BMI of over 30
  • The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
  • The subject has received other intra-articular injections in the 2 months preceding the trial
  • The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular， Hemochromatosis，inflammatory arthropathy，avascular necrosis of femoral head，Paget's disease，hemophilic arthropathy，infectional arthritis，Charcot's disease，villonodular synovitis or synovial chondromatosis
  • The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
  • The subject has a history of alcoholism, drug abuse, or mental illness
  • The subject has participated in any other clinical trial in the 3 months prior to this trial
  • The subject is pregnant, lactating or is planning to conceive within the next 6 months
  • The subject has any other unsuitable or adverse condition to be determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Chinese Armed Police Force

Beijing, China

Location

Shanghai Renji Hospital

Shanghai, 200127, China

Location

Related Publications (1)

  • Lu L, Dai C, Zhang Z, Du H, Li S, Ye P, Fu Q, Zhang L, Wu X, Dong Y, Song Y, Zhao D, Pang Y, Bao C. Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial. Stem Cell Res Ther. 2019 May 21;10(1):143. doi: 10.1186/s13287-019-1248-3.

    PMID: 31113476DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Chunde Bao, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

  • Zhongwen Zhang, MD

    General Hospital of Chinese Armed Police Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

June 13, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

CN(2)