Osteoarthritis, KneePhase 1NCT01485198
Autologous Stem Cells in Osteoarthritis
A Phase 1 study testing Bone Marrow Autologous Stem Cells Infusion and Acetaminophen in people with Osteoarthritis, Knee, run by Hospital Universitario Dr. Jose E. Gonzalez at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Bone Marrow Autologous Stem Cells Infusion and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesMexico
- Study dates
- Aug 2011to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
- Age > 30 years
Who cannot join
- Neurodegenerative, autoimmune, genetic or psychiatric diseases
- Active infection
- Recent joint infection
- Knee surgery history
- Knee joint fracture history
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hematology Service
Monerrey, Nuevo León, 64460
Traumatology Service
Monterrey, Nuevo León, 64460
About this study
Official title: Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee 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)
Read more
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
- Being tested
- Bone Marrow Autologous Stem Cells Infusion, Acetaminophen
- Keywords
- osteoarthritis, knee, stem cell therapy, bone marrow, G-CSF
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Autologous Stem Cells InfusionProcedure or surgery
Also called Knee treatment with stem cells
Extraction and knee infusion of Bone Marrow Autologous Stem Cells
AcetaminophenDrug
Also called Knee treatment with NSAIDs
Acetaminophen (750mg orally TID) administration
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients treated with Acetaminophen Receives: Drug: Acetaminophen |
| Experimental | Experimental | Patients who underwent a BMASC extraction and joint infusion Receives: Procedure: Bone Marrow Autologous Stem Cells Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define safety of BM extraction and stem cell joint infusion.
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.
Measured: 1 week
Secondary outcomes (2)
Efficacy of BMSC joint infusion at 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.
Measured: 4 weeks
Efficacy and final outcome of BMSC joint infusion at 6 months.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Domingo Garay Mendoza, MD, Principal investigator, Hospital Universitario Dr. Jose E. GonzalezConsuelo Mancias Guerra, MD, Study director, Hospital Universitario Dr. Jose E. GonzalezLaura Villarreal Martínez, MD, Study chair, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485198
- Sponsor's protocol ID
- HE11-022
- Status last verified
- Feb 2016
- First submitted
- 26 Nov 2011
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21518322de 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.
PubMed 20934693Chen 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.
PubMed 21300401Garay-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.
PubMed 28752679
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT01485198
- Acronym / sponsor ID
- HE11-022
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, stem cell therapy, bone marrow, G-CSF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: AcetaminophenPatients treated with Acetaminophen |
| Experimental | Experimental | Procedure: Bone Marrow Autologous Stem Cells InfusionPatients who underwent a BMASC extraction and joint infusion |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with knee osteoarthritis grade II or III of the Kellgren-Lawrence radiographic scale
- Age > 30 years
Key exclusion criteria (5 listed)
- Neurodegenerative, autoimmune, genetic or psychiatric diseases
- Active infection
- Recent joint infection
- Knee surgery history
- Knee joint fracture history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Autologous Stem Cells InfusionAlso: Knee treatment with stem cellsExtraction and knee infusion of Bone Marrow Autologous Stem Cells | Procedure or surgery | Experimental |
| AcetaminophenAlso: Knee treatment with NSAIDsAcetaminophen (750mg orally TID) administration | Drug | Control |
Primary outcome
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.
2 secondary outcomes
Efficacy of BMSC joint infusion at 4 weeks
Time frame: 4 weeks
Efficacy and final outcome of BMSC joint infusion at 6 months.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Results publication: PubMed 21518322Davatchi 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.
- Results publication: PubMed 20934693de 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.
- Results publication: PubMed 21300401Chen 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.
- Derived from this study: PubMed 28752679Garay-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.
- Traumatology Service Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domingo Garay Mendoza, MD principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
Consuelo Mancias Guerra, MD study director
Hospital Universitario Dr. Jose E. Gonzalez
Laura Villarreal Martínez, MD study chair
Hospital Universitario Dr. Jose E. Gonzalez
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bone Marrow Autologous Stem Cells Infusion and Acetaminophen in people with Osteoarthritis, Knee, run by Hospital Universitario Dr. Jose E. Gonzalez at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define safety of BM extraction and stem cell joint infusion. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485198, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.