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OpenTrials
Completed

NCT Number: NCT01485198

Autologous Stem Cells in Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hematology Service, Monerrey, Nuevo León, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Marrow Autologous Stem Cells Infusion

Procedure

Extraction and knee infusion of Bone Marrow Autologous Stem Cells

Other names: Knee treatment with stem cells

Acetaminophen

Drug

Acetaminophen (750mg orally TID) administration

Other names: Knee treatment with NSAIDs

Primary outcomes

  1. Define safety of BM extraction and stem cell joint infusion.

    Time frame: 1 week

    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 outcomes

  1. Efficacy of BMSC joint infusion at 4 weeks

    Time frame: 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.

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

    Time frame: 24 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 4 week, first week and baseline questionnaires.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 5, 2011
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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