Clinical trial NCT01485198: Autologous Stem Cells in Osteoarthritis
Official title: Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
knee
stem cell therapy
bone marrow
G-CSF
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Define safety of BM extraction and stem cell joint infusion.
timeFrame: 1 week
Secondary outcomes:
measure: Efficacy of BMSC joint infusion at 4 weeks
timeFrame: 4 weeks
measure: Efficacy and final outcome of BMSC joint infusion at 6 months.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Monerrey
country: Mexico
facility: Hematology Service
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Traumatology Service
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Domingo Garay Mendoza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Consuelo Mancias Guerra, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Laura Villarreal Martínez, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.