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Autologous Stem Cells in Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01485198
First received: November 26, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Procedure: Bone Marrow Autologous Stem Cells Infusion
Drug: Acetaminophen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Define safety of BM extraction and stem cell joint infusion. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Efficacy of BMSC joint infusion at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Efficacy and final outcome of BMSC joint infusion at 6 months. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Patients treated with Acetaminophen
Drug: Acetaminophen
Acetaminophen (750mg orally TID) administration
Other Name: Knee treatment with NSAIDs
Experimental: Experimental
Patients who underwent a BMASC extraction and joint infusion
Procedure: Bone Marrow Autologous Stem Cells Infusion
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
Other Name: Knee treatment with stem cells

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485198

Locations
Mexico
Hematology Service
Monerrey, Nuevo Leon, Mexico, 64460
Traumatology Service
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Domingo Garay Mendoza, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Director: Consuelo Mancias Guerra, MD Hospital Universitario Dr. Jose E. Gonzalez
Study Chair: Laura Villarreal Martínez, MD Hospital Universitario Dr. Jose E. Gonzalez
  More Information

Additional Information:
Publications:
Responsible Party: Consuelo Mancias Guerra, Head of Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01485198     History of Changes
Other Study ID Numbers: HE11-022
Study First Received: November 26, 2011
Last Updated: March 19, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
osteoarthritis
knee
stem cell therapy
bone marrow
G-CSF

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014