Autologous Stem Cells in Osteoarthritis

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01485198

Enrollment

Registered

2011-12-05

Start date

2011-08-31

Completion date

2014-05-31

Last updated

2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

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

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.

Interventions

PROCEDUREBone Marrow Autologous Stem Cells Infusion

Extraction and knee infusion of Bone Marrow Autologous Stem Cells

DRUGAcetaminophen

Acetaminophen (750mg orally TID) administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Define safety of BM extraction and stem cell joint infusion.	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

Measure	Time frame	Description
Efficacy of BMSC joint infusion at 4 weeks	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.
Efficacy and final outcome of BMSC joint infusion at 6 months.	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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026