OsteoarthritisPhase 1/2NCT02123368
Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
A Phase 1/2 study testing Hyaluronic acid, 10 million Bone marrow mesenchimal stem cells and 100 million Bone marrow mesenchimal stem cells in people with Osteoarthritis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hyaluronic acid, 10 million Bone marrow mesenchimal stem cells and 100 million Bone marrow mesenchimal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- May 2012to Feb 2015
- Phase
- Phase 1/2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 50 and 80 year old.
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
- Body mass index between 20 and 35 kg/m2.
- Ability to follow during the study period.
Who cannot join
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
- Previous diagnosis of polyarticular disease.
- Severe mechanical deformation.
- Arthroscopy during the previous 6 months.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
- Systemic autoimmune rheumatic disease.
Show all 13Show fewer
- Poorly controlled diabetes mellitus.
- Blood dyscrasias.
- Immunosuppressive or anticoagulant treatments.
- Treatment with corticosteroids in the 3 months prior to inclusion in the study.
- NSAID therapy within 15 days prior to inclusion in the study.
- Patients with a history of allergy to penicillin or streptomycin.
- Allergy to hyaluronic acid or poultry proteins.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Orthopaedic and traumatology department. Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Traumatology department. Complejo Hospitalario de Salamanca
Salamanca, Castille and León, 37007
About this study
Official title: Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Read more
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
- Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
- Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
Read the detailed description
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
- Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
- Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The autologous mesenchymal stem cells are obtained from the iliac crest and cultured ex vivo under local anesthesia and sedation.
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
All patients met the following inclusion and exclusion criteria:
Inclusion Criteria:
- Males and females between 50 and 80 year old.
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
- Body mass index between 20 and 35 kg/m2.
- Ability to follow during the study period.
Exclusion Criteria:
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
- Previous diagnosis of polyarticular disease.
- Severe mechanical deformation.
- Arthroscopy during the previous 6 months.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
- Systemic autoimmune rheumatic disease.
- Poorly controlled diabetes mellitus.
- Blood dyscrasias.
- Immunosuppressive or anticoagulant treatments.
- Treatment with corticosteroids in the 3 months prior to inclusion in the study.
- NSAID therapy within 15 days prior to inclusion in the study.
- Patients with a history of allergy to penicillin or streptomycin.
- Allergy to hyaluronic acid or poultry proteins.
- Conditions
- Osteoarthritis
- Being tested
- Hyaluronic acid, 10 million Bone marrow mesenchimal stem cells, 100 million Bone marrow mesenchimal stem cells
- Keywords
- Osteoarthritis, Mesenchimal stem cell, Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Also called HyalOne
Single intraarticular injection of Hyaluronic acid (Hyal One)
10 million Bone marrow mesenchimal stem cellsBiological
10 million of Bone marrow mesenchimal stem cells
100 million Bone marrow mesenchimal stem cellsBiological
100 million of Bone marrow mesenchimal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Hialuronic acid | Active comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) Receives: Drug: Hyaluronic acid |
| Hyaluronic acid and MSC 10 | Active comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells Receives: Drug: Hyaluronic acid; Biological: 10 million Bone marrow mesenchimal stem cells |
| Hyaluronic acid AND MSC 100 | Active comparator | Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells Receives: Drug: Hyaluronic acid; Biological: 100 million Bone marrow mesenchimal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Visual analogue scale (VAS)
Baseline Visual analogue scale (VAS)
Measured: prior to the initial dose on day 1
Baseline value of knee injury and osteoarthritis outcome score (Koos).
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Measured: Prior to the intervention on day 1
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Measured: Prior to the intervention on day 1
Baseline SF-36 value
Prior to the intervention on day 1 SF-36 value
Measured: Prior to the intervention on day 1
Baseline euroquol 5D value
Pretreatment euroquol 5D value
Measured: Prior to the intervention on day 1
Baseline Lequesne index
Prior to the intervention on day 1 Lequesne index
Measured: Prior to the intervention on day 1
Baseline femorotibial distance
Prior to the intervention femoritibial distance on rosenberg x-ray view
Measured: Prior to the intervention
Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events
During the follow up
Measured: Follow up
Visual analogue scale (VAS) at on month
Visual analogue scale (VAS) at on month
Measured: 1 month
Visual analogue scale (VAS) at 3 months
Visual analogue scale (VAS) at 3 months
Measured: 3 months
Visual analogue scale (VAS) at 6 months
Visual analogue scale (VAS) at 6 months
Measured: 6 months
Visual analogue scale (VAS) at 12 months
Visual analogue scale (VAS) at 12 months
Measured: 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Measured: 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Measured: 3 Months
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Measured: 6 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Measured: 12 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Measured: 1 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Measured: 3 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month
Measured: 6 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months
Measured: 12 months
SF-36 value at 1 month
SF-36 value
Measured: 1 month
SF 36 value at 3 months
SF 36 value at 3 months
Measured: 3 months
SF 36 value at 6 months
SF 36 value at 6 months
Measured: 6 months
SF 36 value at 12 months
SF 36 value at 12 months
Measured: 12 months
Euroquol 5D value at 1 month
Euroquol 5D value at 1 month
Measured: 1 MOnth
Euroquol 5D value at 3 months
Euroquol 5D value at 3 months
Measured: 3 months
Euroquol 5D value at 6 months
Euroquol 5D value at 6 months
Measured: 6 months
Euroquol 5D value at 12 months
Euroquol 5D value at 12 months
Measured: 12 months
Lequesne index at 1 month
Lequesne index at 1 month
Measured: 1 month
Lequesne index at 3 months
Lequesne index at 3 months
Measured: 3 months
Lequesne index at 6 months
Lequesne index at 6 months
Measured: 6 months
Lequesne index at 12 months
Lequesne index at 12 months
Measured: 12 months
Femorotibial distance at 6 months
Femorotibial distance at 6 months
Measured: 6 months
Femorotibial distance at 12 months
Femorotibial distance at 12 months
Measured: 12 months
Baseline MRI WORMS protocol
Prior to the intervention MRI WORMS protocol
Measured: Prior to the intervention
MRI WORMS protocol score at 6 months
MRI WORMS protocol score at 6 months
Measured: 6 months
MRI WORMS protocol score at 12 months
MRI WORMS protocol score at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Lamo-Espinosa, MD, Principal investigator, Clinica Universidad de NavarraFelipe Prosper, MD PhD, Study director, Clinica Universidad de NavarraJuan Blanco, MD PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123368
- Sponsor's protocol ID
- CMM/ART
- Other IDs
- 2009-017624-72, 2009
- Status last verified
- Oct 2017
- First submitted
- 12 Nov 2013
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2.
PubMed 34895259Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7.
PubMed 30064455Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
PubMed 27565858
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT02123368
- Acronym / sponsor ID
- CMM/ART
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Mesenchimal stem cell, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Apr 2014 (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.
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
- Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
- Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
Detailed description
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
- Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
- Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The autologous mesenchymal stem cells are obtained from the iliac crest and cultured ex vivo under local anesthesia and sedation.
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
- Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
All patients met the following inclusion and exclusion criteria:
Inclusion Criteria:
- Males and females between 50 and 80 year old.
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
- Body mass index between 20 and 35 kg/m2.
- Ability to follow during the study period.
Exclusion Criteria:
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
- Previous diagnosis of polyarticular disease.
- Severe mechanical deformation.
- Arthroscopy during the previous 6 months.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
- Systemic autoimmune rheumatic disease.
- Poorly controlled diabetes mellitus.
- Blood dyscrasias.
- Immunosuppressive or anticoagulant treatments.
- Treatment with corticosteroids in the 3 months prior to inclusion in the study.
- NSAID therapy within 15 days prior to inclusion in the study.
- Patients with a history of allergy to penicillin or streptomycin.
- Allergy to hyaluronic acid or poultry proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hialuronic acid | Active comparator | Drug: Hyaluronic acidSingle intraarticular injection of Hyaluronic acid (Hyal One) |
| Hyaluronic acid and MSC 10 | Active comparator | Drug: Hyaluronic acid, Biological: 10 million Bone marrow mesenchimal stem cellsSingle intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells |
| Hyaluronic acid AND MSC 100 | Active comparator | Drug: Hyaluronic acid, Biological: 100 million Bone marrow mesenchimal stem cellsSingle intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females between 50 and 80 year old.
- Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
- Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
- Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
- Body mass index between 20 and 35 kg/m2.
Key exclusion criteria (13 listed)
- Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
- Previous diagnosis of polyarticular disease.
- Severe mechanical deformation.
- Arthroscopy during the previous 6 months.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
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 |
|---|---|---|
| Hyaluronic acidAlso: HyalOneSingle intraarticular injection of Hyaluronic acid (Hyal One) | Drug | Hialuronic acid, Hyaluronic acid AND MSC 100, Hyaluronic acid and MSC 10 |
| 10 million Bone marrow mesenchimal stem cells10 million of Bone marrow mesenchimal stem cells | Biological | Hyaluronic acid and MSC 10 |
| 100 million Bone marrow mesenchimal stem cells100 million of Bone marrow mesenchimal stem cells | Biological | Hyaluronic acid AND MSC 100 |
Primary outcome
Baseline Visual analogue scale (VAS)
Time frame: prior to the initial dose on day 1
Baseline Visual analogue scale (VAS)
Baseline value of knee injury and osteoarthritis outcome score (Koos).
Time frame: Prior to the intervention on day 1
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Time frame: Prior to the intervention on day 1
Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
Baseline SF-36 value
Time frame: Prior to the intervention on day 1
Prior to the intervention on day 1 SF-36 value
Baseline euroquol 5D value
Time frame: Prior to the intervention on day 1
Pretreatment euroquol 5D value
Baseline Lequesne index
Time frame: Prior to the intervention on day 1
Prior to the intervention on day 1 Lequesne index
Baseline femorotibial distance
Time frame: Prior to the intervention
Prior to the intervention femoritibial distance on rosenberg x-ray view
Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Follow up
During the follow up
Visual analogue scale (VAS) at on month
Time frame: 1 month
Visual analogue scale (VAS) at on month
Visual analogue scale (VAS) at 3 months
Time frame: 3 months
Visual analogue scale (VAS) at 3 months
Visual analogue scale (VAS) at 6 months
Time frame: 6 months
Visual analogue scale (VAS) at 6 months
Visual analogue scale (VAS) at 12 months
Time frame: 12 months
Visual analogue scale (VAS) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Time frame: 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Time frame: 3 Months
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Time frame: 6 months
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Time frame: 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Time frame: 1 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month
Time frame: 3 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month
Time frame: 6 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months
Time frame: 12 months
Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months
SF-36 value at 1 month
Time frame: 1 month
SF-36 value
SF 36 value at 3 months
Time frame: 3 months
SF 36 value at 3 months
SF 36 value at 6 months
Time frame: 6 months
SF 36 value at 6 months
SF 36 value at 12 months
Time frame: 12 months
SF 36 value at 12 months
Euroquol 5D value at 1 month
Time frame: 1 MOnth
Euroquol 5D value at 1 month
Euroquol 5D value at 3 months
Time frame: 3 months
Euroquol 5D value at 3 months
Euroquol 5D value at 6 months
Time frame: 6 months
Euroquol 5D value at 6 months
Euroquol 5D value at 12 months
Time frame: 12 months
Euroquol 5D value at 12 months
Lequesne index at 1 month
Time frame: 1 month
Lequesne index at 1 month
Lequesne index at 3 months
Time frame: 3 months
Lequesne index at 3 months
Lequesne index at 6 months
Time frame: 6 months
Lequesne index at 6 months
Lequesne index at 12 months
Time frame: 12 months
Lequesne index at 12 months
Femorotibial distance at 6 months
Time frame: 6 months
Femorotibial distance at 6 months
Femorotibial distance at 12 months
Time frame: 12 months
Femorotibial distance at 12 months
Baseline MRI WORMS protocol
Time frame: Prior to the intervention
Prior to the intervention MRI WORMS protocol
MRI WORMS protocol score at 6 months
Time frame: 6 months
MRI WORMS protocol score at 6 months
MRI WORMS protocol score at 12 months
Time frame: 12 months
MRI WORMS protocol score at 12 months
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 24 Oct 2017.
- Derived from this study: PubMed 34895259Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2.
- Derived from this study: PubMed 30064455Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7.
- Derived from this study: PubMed 27565858Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
- University clinic of navarre trial informationLink 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.
José Lamo-Espinosa, MD principal investigator
Clinica Universidad de Navarra
Felipe Prosper, MD PhD study director
Clinica Universidad de Navarra
Juan Blanco, MD PhD principal investigator
University of Salamanca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyaluronic acid, 10 million Bone marrow mesenchimal stem cells and 100 million Bone marrow mesenchimal stem cells in people with Osteoarthritis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
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 6 inclusion and 13 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 24 Oct 2017. 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 Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Baseline Visual analogue scale (VAS) (time frame: prior to the initial dose on day 1). The study lists 37 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 NCT02123368, which also lists 3 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 24 Oct 2017.