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Autologous Stem Cells in Osteoarthritis

NCT01485198 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-03-01

No results posted yet for this study

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

Interventions

PROCEDURE

Bone Marrow Autologous Stem Cells Infusion

Extraction and knee infusion of Bone Marrow Autologous Stem Cells

DRUG

Acetaminophen

Acetaminophen (750mg orally TID) administration

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

  • Domingo Garay Mendoza, MD · Hospital Universitario Dr. Jose E. Gonzalez

  • Consuelo Mancias Guerra, MD · Hospital Universitario Dr. Jose E. Gonzalez

  • Laura Villarreal Martínez, MD · Hospital Universitario Dr. Jose E. Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-08-31
Completion
2014-05-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485198 on ClinicalTrials.gov