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

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ClinicalTrials.gov Identifier: NCT02237846
Recruitment Status : Withdrawn (No enrollment)
First Posted : September 11, 2014
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: Human umbilical cord tissue-derived mesenchymal stem cells Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Study Start Date : September 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 3 months and 12 months ]

Secondary Outcome Measures :
  1. Number of participants with a change in joint function from baseline WOMAC assessment [ Time Frame: 3 months and 12 months ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237846


Locations
Panama
Stem Cell Instsitute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Principal Investigator: Salomon Dayan, MD

Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02237846     History of Changes
Other Study ID Numbers: CNEI-2014-TBS-UCMSCOA-001
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Translational Biosciences:
osteoarthritis
knee
stem cells
mesenchymal
umbilical cord

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases