Autologous Stem Cells in Osteoarthritis

NCT01485198 | Completed Phase 1 DMC

• 1 other identifier: HE11-022
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; knee; stem cell therapy; bone marrow; G-CSF

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Efficacy of BMSC joint infusion at 4 weeks

  4 weeks

• Efficacy and final outcome of BMSC joint infusion at 6 months.

  24 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients treated with Acetaminophen

Drug: Acetaminophen

Experimental

EXPERIMENTAL

Patients who underwent a BMASC extraction and joint infusion

Procedure: Bone Marrow Autologous Stem Cells Infusion

Interventions

Bone Marrow Autologous Stem Cells Infusion PROCEDURE

Extraction and knee infusion of Bone Marrow Autologous Stem Cells

Also known as: Knee treatment with stem cells

Experimental

Acetaminophen DRUG

Acetaminophen (750mg orally TID) administration

Also known as: Knee treatment with NSAIDs

Control

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
• Age \> 30 years

You may not qualify if:

• Neurodegenerative, autoimmune, genetic or psychiatric diseases
• Active infection
• Recent joint infection
• Knee surgery history
• Knee joint fracture history

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (2)

Hematology Service

Monerrey, Nuevo León, 64460, Mexico

Location

Traumatology Service

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (4)

• 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.

  PMID: 21518322 RESULT

• 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 crest and subchondral bone. Injury. 2010 Nov;41(11):1172-7. doi: 10.1016/j.injury.2010.09.027. Epub 2010 Oct 8.

  PMID: 20934693 RESULT

• 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.

  PMID: 21300401 RESULT

• Garay-Mendoza D, Villarreal-Martinez L, Garza-Bedolla A, Perez-Garza DM, Acosta-Olivo C, Vilchez-Cavazos F, Diaz-Hutchinson C, Gomez-Almaguer D, Jaime-Perez JC, Mancias-Guerra C. The effect of intra-articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis. Int J Rheum Dis. 2018 Jan;21(1):140-147. doi: 10.1111/1756-185X.13139. Epub 2017 Jul 27.

  PMID: 28752679 DERIVED

Related Links

• Traumatology Service Web Site

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Domingo Garay Mendoza, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

• Consuelo Mancias Guerra, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  STUDY DIRECTOR

• Laura Villarreal Martínez, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology Service

Study Record Dates

• First Submitted: November 26, 2011
• First Posted: December 5, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

ME (2)