Osteo Arthritis KneePhase 3NCT04351932
Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
A Phase 3 study testing bone marrow mesenchymal stem cells, Adipose Mesenchymal stem cells and bone marrow & adipose mesenchymal stem cells injection in people with Osteo Arthritis Knee, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
Trial summary
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- bone marrow mesenchymal stem cells, Adipose Mesenchymal stem cells and bone marrow & adipose mesenchymal stem cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEcuador
- Study dates
- 7 Jun 2020to 7 Sep 2021
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
- Minimal VAS pain score of 4.
- Chronic knee pain of mechanical origin.
- All patients who sign a specially prepared informed consent for this clinical trial.
Who cannot join
- Varus or valgus knee mal alignment superior to 10°.
- OA grade IV according Ahlbäck classification.
- Bone marrow cancer like lymphoma.
- Severe anemia.
- Active infections.
- Pregnant patients.
Show all 10Show fewer
- Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
- Bone diseases such as Kahler and Paget.
- Corticoesteroid and hyaluronic injections within the last 3 months.
- Knee surgery in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Omnihospital
Guayaquil, Guayas, 9018
Carlos Chiriboga, 593 9 99954148, drcarloschiriboga@gmail.com
About this study
Official title: Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).
Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.
Read the detailed description
The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.
To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.
A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
- Conditions
- Osteo Arthritis Knee
- Being tested
- bone marrow mesenchymal stem cells, Adipose Mesenchymal stem cells, bone marrow & adipose mesenchymal stem cells injection
- Keywords
- Mesenchymal stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow mesenchymal stem cellsBiological
intrarticular bone marrow mesenchymal stem cells injection
Adipose Mesenchymal stem cellsBiological
intrarticular adipose mesenchymal stem cells injection
bone marrow & adipose mesenchymal stem cells injectionBiological
intrarticular bone marrow and adipose stem cells injection.
| Study group | Role | What they receive |
|---|---|---|
| bone marrow mesenchymal stem cell | Active comparator | Bone marrow mesenchymal stem cells 10 cc by intra articular injection once Receives: Biological: bone marrow mesenchymal stem cells |
| adipose mesenchymal stem cells | Active comparator | Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once Receives: Biological: Adipose Mesenchymal stem cells |
| Bone marrow and Adipose mesenchymal stem cells | Active comparator | Bone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once. Receives: Biological: bone marrow & adipose mesenchymal stem cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee pain assessed by Visual Analogue Scale.
psychometric response scale which used in questionnaires. It is a measurement instrument for subjective characteristics of pain . Score from O to 10. O indicate no pain, and 10 indicate the worst pain.
Measured: 12 months
knee function assessed by WOMAC (Wester Ontario McMaster Osteoarthritis Index). quosteionary.
The Index contains 24 questions five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Individual question responses are assigned a score of between 0 (extreme) and 4 (None). Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Finally, raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).
Measured: 12 months
Secondary outcomes (1)
Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix
MRI T2 mapping of the cartilage is a non-invasive functional imaging technique delivering cartography of the T2 relaxation time of the cartilage without any contrast injection. It is sensitive to tissue anisotropy, and provides compositional information on the cartilage collagen network, water content and proteoglycans concentration.
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start7 Jun 2020 (estimated)
- Primary completion7 Jun 2021 (estimated)
- Study completion7 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 2 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica Santiago de Guayaquil
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Dr. Carlos Chiriboga Accini, Universidad Catolica Santiago de Guayaquil
- Investigators
- Carlos A Chiriboga, MD, Principal investigator, Universidad Católica Santiago de Guayaquil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351932
- Sponsor's protocol ID
- UCSantiagodeGuayaquil001
- Status last verified
- Apr 2020
- First submitted
- 4 May 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Wagner W, Wein F, Seckinger A, Frankhauser M, Wirkner U, Krause U, Blake J, Schwager C, Eckstein V, Ansorge W, Ho AD. Comparative characteristics of mesenchymal stem cells from human bone marrow, adipose tissue, and umbilical cord blood. Exp Hematol. 2005 Nov;33(11):1402-16. doi: 10.1016/j.exphem.2005.07.003.
PubMed 16263424Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
PubMed 11869080Xia P, Wang X, Lin Q, Li X. Efficacy of mesenchymal stem cells injection for the management of knee osteoarthritis: a systematic review and meta-analysis. Int Orthop. 2015 Dec;39(12):2363-72. doi: 10.1007/s00264-015-2785-8. Epub 2015 May 6.
PubMed 25944079Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.
PubMed 20603892Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.
PubMed 24449146Peeters CM, Leijs MJ, Reijman M, van Osch GJ, Bos PK. Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review. Osteoarthritis Cartilage. 2013 Oct;21(10):1465-73. doi: 10.1016/j.joca.2013.06.025. Epub 2013 Jul 4.
PubMed 23831631Freitag J, Bates D, Boyd R, Shah K, Barnard A, Huguenin L, Tenen A. Mesenchymal stem cell therapy in the treatment of osteoarthritis: reparative pathways, safety and efficacy - a review. BMC Musculoskelet Disord. 2016 May 26;17:230. doi: 10.1186/s12891-016-1085-9.
PubMed 27229856
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04351932
- Acronym / sponsor ID
- UCSantiagodeGuayaquil001
- Conditions
- Osteo Arthritis Knee
- Keywords
- Mesenchymal stem cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidad Catolica Santiago de GuayaquilUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 7 Jun 2020 (estimated)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 7 Sep 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- 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.
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).
Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.
Detailed description
The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.
To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.
A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 2 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
| Arm | Type | Receives |
|---|---|---|
| bone marrow mesenchymal stem cell | Active comparator | Biological: bone marrow mesenchymal stem cellsBone marrow mesenchymal stem cells 10 cc by intra articular injection once |
| adipose mesenchymal stem cells | Active comparator | Biological: Adipose Mesenchymal stem cellsStromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once |
| Bone marrow and Adipose mesenchymal stem cells | Active comparator | Biological: bone marrow & adipose mesenchymal stem cells injectionBone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
- Minimal VAS pain score of 4.
- Chronic knee pain of mechanical origin.
- All patients who sign a specially prepared informed consent for this clinical trial.
Key exclusion criteria (10 listed)
- Varus or valgus knee mal alignment superior to 10°.
- OA grade IV according Ahlbäck classification.
- Bone marrow cancer like lymphoma.
- Severe anemia.
- Active infections.
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 mesenchymal stem cellsintrarticular bone marrow mesenchymal stem cells injection | Biological | bone marrow mesenchymal stem cell |
| Adipose Mesenchymal stem cellsintrarticular adipose mesenchymal stem cells injection | Biological | adipose mesenchymal stem cells |
| bone marrow & adipose mesenchymal stem cells injectionintrarticular bone marrow and adipose stem cells injection. | Biological | Bone marrow and Adipose mesenchymal stem cells |
Primary outcome
knee pain assessed by Visual Analogue Scale.
Time frame: 12 months
psychometric response scale which used in questionnaires. It is a measurement instrument for subjective characteristics of pain . Score from O to 10. O indicate no pain, and 10 indicate the worst pain.
knee function assessed by WOMAC (Wester Ontario McMaster Osteoarthritis Index). quosteionary.
Time frame: 12 months
The Index contains 24 questions five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Individual question responses are assigned a score of between 0 (extreme) and 4 (None). Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Finally, raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).
1 secondary outcome
Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix
Time frame: 6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Results publication: PubMed 16263424Wagner W, Wein F, Seckinger A, Frankhauser M, Wirkner U, Krause U, Blake J, Schwager C, Eckstein V, Ansorge W, Ho AD. Comparative characteristics of mesenchymal stem cells from human bone marrow, adipose tissue, and umbilical cord blood. Exp Hematol. 2005 Nov;33(11):1402-16. doi: 10.1016/j.exphem.2005.07.003.
- Results publication: PubMed 11869080Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
- Results publication: PubMed 25944079Xia P, Wang X, Lin Q, Li X. Efficacy of mesenchymal stem cells injection for the management of knee osteoarthritis: a systematic review and meta-analysis. Int Orthop. 2015 Dec;39(12):2363-72. doi: 10.1007/s00264-015-2785-8. Epub 2015 May 6.
- Results publication: PubMed 20603892Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.
- Results publication: PubMed 24449146Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.
- Results publication: PubMed 23831631Peeters CM, Leijs MJ, Reijman M, van Osch GJ, Bos PK. Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review. Osteoarthritis Cartilage. 2013 Oct;21(10):1465-73. doi: 10.1016/j.joca.2013.06.025. Epub 2013 Jul 4.
- Results publication: PubMed 27229856Freitag J, Bates D, Boyd R, Shah K, Barnard A, Huguenin L, Tenen A. Mesenchymal stem cell therapy in the treatment of osteoarthritis: reparative pathways, safety and efficacy - a review. BMC Musculoskelet Disord. 2016 May 26;17:230. doi: 10.1186/s12891-016-1085-9.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Carlos A Chiriboga, MD principal investigator
Universidad Católica Santiago de Guayaquil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bone marrow mesenchymal stem cells, Adipose Mesenchymal stem cells and bone marrow & adipose mesenchymal stem cells injection in people with Osteo Arthritis Knee, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Chiriboga, MD (593 9 9995 4148, drcarloschiriboga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee pain assessed by Visual Analogue Scale. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04351932, which also lists 7 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 17 Apr 2020.