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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04351932
• Other study ID #: UCSantiagodeGuayaquil001
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 7, 2020
• Est. completion date: September 7, 2021

Study information

• Verified date: April 2020
• Source: Universidad Catolica Santiago de Guayaquil
• Contact: Carlos A Chiriboga, MD
• Phone: 593 9 9995 4148
• Email: drcarloschiriboga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: September 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• bone marrow mesenchymal stem cells
intrarticular bone marrow mesenchymal stem cells injection
• Adipose Mesenchymal stem cells
intrarticular adipose mesenchymal stem cells injection
• bone marrow & adipose mesenchymal stem cells injection
intrarticular bone marrow and adipose stem cells injection.

Locations

Country	Name	City	State
Ecuador	Omnihospital	Guayaquil	Guayas

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Catolica Santiago de Guayaquil	Maastricht University Medical Center

Country where clinical trial is conducted

Ecuador, 

References & Publications (7)

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/s12891-01 — View Citation

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. 2 — View Citation

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. Ep — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix	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