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Human Autologous MSCs for the Treatment of Mid to Late Stage Knee OA

NCT02351011 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-09-27

No results posted yet for this study

Summary

Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.

Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. This will be done by starting at a low dose of MSCs and moving on to the next higher dose level provided there are no safety concerns. Researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.

Conditions

  • Osteoarthritis of Knee

Interventions

BIOLOGICAL

1 x 10^6 MSCs

Autologous, bone-marrow derived MSCs

BIOLOGICAL

10 x 10^6 MSCs

Autologous, bone-marrow derived MSCs

BIOLOGICAL

50 x 10^6 MSCs

Autologous, bone-marrow derived MSCs

Sponsors & Collaborators

  • Jas Chahal

    lead OTHER

Principal Investigators

  • Jas Chahal, MD, MSc · Arthritis Program, Toronto Western Hospital

  • Sowmya Viswanathan, PhD · Arthritis Program, Toronto Western Hospital & Philip S. Orsino Facility for Cell Therapy

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351011 on ClinicalTrials.gov