Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

April 16, 2020 updated by: Dr. Carlos Chiriboga Accini, Universidad Catolica Santiago de Guayaquil

Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial

Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).

Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.

To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.

A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.

A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 3

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

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 9018
        • Omnihospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
  • Minimal VAS pain score of 4.
  • Chronic knee pain of mechanical origin.
  • All patients who sign a specially prepared informed consent for this clinical trial.

Exclusion Criteria:

  • Varus or valgus knee mal alignment superior to 10°.
  • OA grade IV according Ahlbäck classification.
  • Bone marrow cancer like lymphoma.
  • Severe anemia.
  • Active infections.
  • Pregnant patients.
  • Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
  • Bone diseases such as Kahler and Paget.
  • Corticoesteroid and hyaluronic injections within the last 3 months.
  • Knee surgery in the last 6 months.

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: bone marrow mesenchymal stem cell
Bone marrow mesenchymal stem cells 10 cc by intra articular injection once
Biological: bone marrow mesenchymal stem cells
intrarticular bone marrow mesenchymal stem cells injection
Active Comparator: adipose mesenchymal stem cells
Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once
Biological: Adipose Mesenchymal stem cells
intrarticular adipose mesenchymal stem cells injection
Active Comparator: Bone marrow and Adipose mesenchymal stem cells
Bone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once.
Biological: bone marrow & adipose mesenchymal stem cells injection
intrarticular bone marrow and adipose stem cells injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee pain assessed by Visual Analogue Scale.
Time Frame: 12 months
psychometric response scale which used in questionnaires. It is a measurement instrument for subjective characteristics of pain . Score from O to 10. O indicate no pain, and 10 indicate the worst pain.
12 months
knee function assessed by WOMAC (Wester Ontario McMaster Osteoarthritis Index). quosteionary.
Time Frame: 12 months
The Index contains 24 questions five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Individual question responses are assigned a score of between 0 (extreme) and 4 (None). Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Finally, raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix
Time Frame: 6 months after procedure
MRI T2 mapping of the cartilage is a non-invasive functional imaging technique delivering cartography of the T2 relaxation time of the cartilage without any contrast injection. It is sensitive to tissue anisotropy, and provides compositional information on the cartilage collagen network, water content and proteoglycans concentration.
6 months after procedure

Collaborators and Investigators

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

Sponsor

Universidad Catolica Santiago de Guayaquil

Collaborators

Maastricht University Medical Center

Investigators

  • Principal Investigator: Carlos A Chiriboga, MD, Universidad Catolica Santiago de Guayaquil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 7, 2020

Primary Completion (Anticipated)

June 7, 2021

Study Completion (Anticipated)

September 7, 2021

Study Registration Dates

First Submitted

May 4, 2019

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSantiagodeGuayaquil001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

JUNE 2021 TO SEPTEMBER 2021

IPD Sharing Access Criteria

drcarloschiriboga@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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