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

Primary Purpose

Osteoarthritis of the Knee

Status
Withdrawn
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Human umbilical cord tissue-derived mesenchymal stem cells
Sponsored by
Translational Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, stem cells, mesenchymal, umbilical cord

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stem Cell Instsitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intra-articular knee injection of UC-MSC

IV injection of UC-MSC

Arm Description

Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once

Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Number of participants with a change in joint function from baseline WOMAC assessment
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system

Full Information

First Posted
September 9, 2014
Last Updated
August 8, 2017
Sponsor
Translational Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT02237846
Brief Title
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Official Title
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollment
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Biosciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, stem cells, mesenchymal, umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular knee injection of UC-MSC
Arm Type
Active Comparator
Arm Description
Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once
Arm Title
IV injection of UC-MSC
Arm Type
Active Comparator
Arm Description
Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days
Intervention Type
Biological
Intervention Name(s)
Human umbilical cord tissue-derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
3 months and 12 months
Secondary Outcome Measure Information:
Title
Number of participants with a change in joint function from baseline WOMAC assessment
Time Frame
3 months and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salomon Dayan, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cell Instsitute
City
Panama City
Country
Panama

12. IPD Sharing Statement

Learn more about this trial

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

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