Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis

August 8, 2017 updated by: Translational Biosciences
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect in osteoarthritis (OA) patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will receive IV UC-MSC once per day for 3 consecutive days.

The primary objective of the trial is freedom from treatment associated adverse events at 3 and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline, and 3 and 12 months post treatment and will be quantified based on the Western Ontario and McMaster osteoarthritis index (WOMAC).

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Stem Cell Instsitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent by the subject.
  • Age greater than or equal to 18 years
  • Ability to understand the planned treatment.
  • Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Exclusion Criteria:

  • Pregnant or lactating women
  • Women of childbearing potential unwilling to use two forms of contraception
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intra-articular knee injection of UC-MSC
Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once
Biological: Human umbilical cord tissue-derived mesenchymal stem cells
Active Comparator: IV injection of UC-MSC
Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days
Biological: Human umbilical cord tissue-derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 3 months and 12 months
3 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with a change in joint function from baseline WOMAC assessment
Time Frame: 3 months and 12 months
3 months and 12 months
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system
Time Frame: 3 months and 12 months
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Biosciences

Investigators

  • Principal Investigator: Salomon Dayan, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNEI-2014-TBS-UCMSCOA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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