Autologous Stem Cells in Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485198
• Other study ID #: HE11-022
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2011
• Last updated: February 29, 2016
• Start date: August 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups:

• The control group will receive Acetaminophen 750mg orally every 8 hours

• The experimental group will receive Autologous Hematopoietic Stem Cells from bone marrow (BMASC)

Signed informed consent is required, as well as answering a questionnaire.

Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia.

The procedure is ambulatory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale

• Age > 30 years

Exclusion Criteria:

• Neurodegenerative, autoimmune, genetic or psychiatric diseases

• Active infection

• Recent joint infection

• Knee surgery history

• Knee joint fracture history

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Bone Marrow Autologous Stem Cells Infusion
Extraction and knee infusion of Bone Marrow Autologous Stem Cells

Drug:
• Acetaminophen
Acetaminophen (750mg orally TID) administration

Locations

Country	Name	City	State
Mexico	Hematology Service	Monerrey	Nuevo Leon
Mexico	Traumatology Service	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Chen FM, Wu LA, Zhang M, Zhang R, Sun HH. Homing of endogenous stem/progenitor cells for in situ tissue regeneration: Promises, strategies, and translational perspectives. Biomaterials. 2011 Apr;32(12):3189-209. doi: 10.1016/j.biomaterials.2010.12.032. Re — View Citation

Davatchi F, Abdollahi BS, Mohyeddin M, Shahram F, Nikbin B. Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis. 2011 May;14(2):211-5. doi: 10.1111/j.1756-185X.2011.01599.x. Epub 2011 Mar 4. — View Citation

de Girolamo L, Bertolini G, Cervellin M, Sozzi G, Volpi P. Treatment of chondral defects of the knee with one step matrix-assisted technique enhanced by autologous concentrated bone marrow: in vitro characterisation of mesenchymal stem cells from iliac cr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define safety of BM extraction and stem cell joint infusion.	Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.; Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire.	1 week	Yes
Secondary	Efficacy of BMSC joint infusion at 4 weeks	Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.; Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with first week and baseline questionnaires.	4 weeks	Yes
Secondary	Efficacy and final outcome of BMSC joint infusion at 6 months.	Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination.; Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with 4 week, first week and baseline questionnaires.	24 weeks	Yes

External Links

•   Hematology Service Web Site
•   Traumatology Service Web Site