NCT04351932

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

May 4, 2019

Last Update Submit

April 16, 2020

Conditions

Osteo Arthritis Knee

Keywords

Mesenchymal stem cell

Outcome Measures

Primary Outcomes (2)

  • knee pain assessed by Visual Analogue Scale.

    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.

    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 Outcomes (1)

  • Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix

    6 months after procedure

Study Arms (3)

bone marrow mesenchymal stem cell

ACTIVE COMPARATOR

Bone marrow mesenchymal stem cells 10 cc by intra articular injection once

Biological: bone marrow mesenchymal stem cells

adipose mesenchymal stem cells

ACTIVE COMPARATOR

Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once

Biological: Adipose Mesenchymal stem cells

Bone marrow and Adipose mesenchymal stem cells

ACTIVE COMPARATOR

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

Interventions

bone marrow mesenchymal stem cellsBIOLOGICAL

intrarticular bone marrow mesenchymal stem cells injection

bone marrow mesenchymal stem cell
Adipose Mesenchymal stem cellsBIOLOGICAL

intrarticular adipose mesenchymal stem cells injection

adipose mesenchymal stem cells
bone marrow & adipose mesenchymal stem cells injectionBIOLOGICAL

intrarticular bone marrow and adipose stem cells injection.

Bone marrow and Adipose mesenchymal stem cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omnihospital

Guayaquil, Guayas, 9018, Ecuador

Location

Related Publications (7)

  • Wagner W, Wein F, Seckinger A, Frankhauser M, Wirkner U, Krause U, Blake J, Schwager C, Eckstein V, Ansorge W, Ho AD. Comparative characteristics of mesenchymal stem cells from human bone marrow, adipose tissue, and umbilical cord blood. Exp Hematol. 2005 Nov;33(11):1402-16. doi: 10.1016/j.exphem.2005.07.003.

    PMID: 16263424RESULT

  • Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.

    PMID: 11869080RESULT

  • Xia P, Wang X, Lin Q, Li X. Efficacy of mesenchymal stem cells injection for the management of knee osteoarthritis: a systematic review and meta-analysis. Int Orthop. 2015 Dec;39(12):2363-72. doi: 10.1007/s00264-015-2785-8. Epub 2015 May 6.

    PMID: 25944079RESULT

  • Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.

    PMID: 20603892RESULT

  • Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.

    PMID: 24449146RESULT

  • Peeters CM, Leijs MJ, Reijman M, van Osch GJ, Bos PK. Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review. Osteoarthritis Cartilage. 2013 Oct;21(10):1465-73. doi: 10.1016/j.joca.2013.06.025. Epub 2013 Jul 4.

    PMID: 23831631RESULT

  • Freitag J, Bates D, Boyd R, Shah K, Barnard A, Huguenin L, Tenen A. Mesenchymal stem cell therapy in the treatment of osteoarthritis: reparative pathways, safety and efficacy - a review. BMC Musculoskelet Disord. 2016 May 26;17:230. doi: 10.1186/s12891-016-1085-9.

    PMID: 27229856RESULT

Study Officials

  • Carlos A Chiriboga, MD

    Universidad Católica Santiago de Guayaquil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Chiriboga, MD

CONTACT

593 9 9995 4148drcarloschiriboga@gmail.com

Peter A Chedraui, Phd

CONTACT

593 9 9942 4629peter.chedraui@cu.ucsg.edu.ec

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
A randomized non blind clinical trial with active control. For this purpose, the random number generator, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 2 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor. Orthopaedic Staff. Omnihospital.

Study Record Dates

First Submitted

May 4, 2019

First Posted

April 17, 2020

Study Start

June 7, 2020

Primary Completion

June 7, 2021

Study Completion

September 7, 2021

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
JUNE 2021 TO SEPTEMBER 2021
Access Criteria
drcarloschiriboga@gmail.com

Locations

EC(1)