Chronic DiseasePhase 2msctendonrepNCT01687777
Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair
A Phase 2 study testing Mesenchymal Stem Cells (MSCs) and OrthADAPT in people with Chronic Disease, run by Hospital San Carlos, Madrid at 2 sites in Spain.
Trial summary
Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Mesenchymal Stem Cells (MSCs) and OrthADAPT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- May 2010to Dec 2013
- Phase
- Phase 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject providing informed consent.
- Comprised subject male/female aged 55-80.
- Subject has a supraspinatus tendon rupture.
- Subject has an unilateral injury.
- Rupture is enough to need medical assistance.
- Subject has an conventional medical treatment fail at least 3 months.
- Subject has a "reparable" injury according to Goutallier´s criteria.
Who cannot join
- Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Clinico San Carlos
Madrid, Madrid, 28040
Benjamin Fernandez-Gutierrez, MD, PhD, +34913303615 ext. 7803, bfernandez.hcsc@salud.madrid.org
Pilar Tornero-Esteban, Bs, PhD, +34913303615 ext. 7434, mptornero@gmail.com
- Recruiting
Hospital Universitario Clinico San Carlos
Madrid, Madrid, 28040
Benjamin Fernandez-Gutierrez, MD, PhD, +34913303615 ext. 7803, bfernandez.hcsc@salud.madrid.org
Pilar Tornero-Esteban, Bs,PhD, +34913303615 ext. 7434, mptornero@gmail.com
About this study
Official title: Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.
Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.
Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.
Read the detailed description
The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups.
The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls.
The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.
- Conditions
- Chronic Disease
- Being tested
- Mesenchymal Stem Cells (MSCs), OrthADAPT
- Keywords
- Supraspinatus tendon, Mesenchymal stem cells, OrthADAPT, Rotator cuff
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSCs)Biological
20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
OrthADAPTBiological
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells (MSCs) | Active comparator | Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT) Receives: Biological: Mesenchymal Stem Cells (MSCs) |
| OrthADAPT | Placebo comparator | Membrane of collagen type I (OrthoADAPT) Receives: Biological: OrthADAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score
Measured: up to 1 year
Secondary outcomes (1)
Nuclear Magnetic Resonance (RMN)
Measured: 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startMay 2010
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Responsible party
- Principal investigator, Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid
- Investigators
- Benjamin Fernandez-Gutierrez, MD, PhD, Principal investigator, Hospital Universitario Clinico San CarlosPilar Tornero-Esteban, Bs, PhD, Study director, Hospital Universitario Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687777
- Sponsor's protocol ID
- EC07/90208
- Other IDs
- 2007-007630-19
- Acronym
- msctendonrep
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267.
PubMed 10434073Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31. doi: 10.1016/S0736-0266(02)00163-8.
PubMed 12706014Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. 2009 Nov;25(11):1233-9. doi: 10.1016/j.arthro.2009.05.012. Epub 2009 Oct 2.
PubMed 19896044Bruder SP, Jaiswal N, Haynesworth SE. Growth kinetics, self-renewal, and the osteogenic potential of purified human mesenchymal stem cells during extensive subcultivation and following cryopreservation. J Cell Biochem. 1997 Feb;64(2):278-94. doi: 10.1002/(sici)1097-4644(199702)64:23.0.co;2-f.
PubMed 9027588Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96. doi: 10.2106/00004623-199807000-00007.
PubMed 9698003Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
PubMed 1870029Caplan AI. The mesengenic process. Clin Plast Surg. 1994 Jul;21(3):429-35.
PubMed 7924141Caplan AI. Review: mesenchymal stem cells: cell-based reconstructive therapy in orthopedics. Tissue Eng. 2005 Jul-Aug;11(7-8):1198-211. doi: 10.1089/ten.2005.11.1198.
PubMed 16144456Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM. Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Joint Surg Am. 2001 Jan;83(1):71-7. doi: 10.2106/00004623-200101000-00010.
PubMed 11205861Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.
PubMed 11741065Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
PubMed 14960664Gimbel JA, Van Kleunen JP, Lake SP, Williams GR, Soslowsky LJ. The role of repair tension on tendon to bone healing in an animal model of chronic rotator cuff tears. J Biomech. 2007;40(3):561-8. doi: 10.1016/j.jbiomech.2006.02.010. Epub 2006 Apr 4.
PubMed 16600252Goutallier D, Postel JM, Gleyze P, Leguilloux P, Van Driessche S. Influence of cuff muscle fatty degeneration on anatomic and functional outcomes after simple suture of full-thickness tears. J Shoulder Elbow Surg. 2003 Nov-Dec;12(6):550-4. doi: 10.1016/s1058-2746(03)00211-8.
PubMed 14671517Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
PubMed 1874784Jaiswal N, Haynesworth SE, Caplan AI, Bruder SP. Osteogenic differentiation of purified, culture-expanded human mesenchymal stem cells in vitro. J Cell Biochem. 1997 Feb;64(2):295-312.
PubMed 9027589
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT01687777
- Acronym / sponsor ID
- msctendonrep / EC07/90208
- Conditions
- Chronic Disease
- Keywords
- Supraspinatus tendon, Mesenchymal stem cells, OrthADAPT, Rotator cuff
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Study start
- May 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Sep 2012 (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.
Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.
Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.
Detailed description
The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups.
The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls.
The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells (MSCs) | Active comparator | Biological: Mesenchymal Stem Cells (MSCs)Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT) |
| OrthADAPT | Placebo comparator | Biological: OrthADAPTMembrane of collagen type I (OrthoADAPT) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject providing informed consent.
- Comprised subject male/female aged 55-80.
- Subject has a supraspinatus tendon rupture.
- Subject has an unilateral injury.
- Rupture is enough to need medical assistance.
Key exclusion criteria (1 listed)
- Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.
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 |
|---|---|---|
| Mesenchymal Stem Cells (MSCs)20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage. | Biological | Mesenchymal stem cells (MSCs) |
| OrthADAPT | Biological | OrthADAPT |
Primary outcome
Constant Shoulder Score
Time frame: up to 1 year
1 secondary outcome
Nuclear Magnetic Resonance (RMN)
Time frame: 6 months, one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Background: PubMed 10434073Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267.
- Background: PubMed 12706014Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31. doi: 10.1016/S0736-0266(02)00163-8.
- Background: PubMed 19896044Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. 2009 Nov;25(11):1233-9. doi: 10.1016/j.arthro.2009.05.012. Epub 2009 Oct 2.
- Background: PubMed 9027588Bruder SP, Jaiswal N, Haynesworth SE. Growth kinetics, self-renewal, and the osteogenic potential of purified human mesenchymal stem cells during extensive subcultivation and following cryopreservation. J Cell Biochem. 1997 Feb;64(2):278-94. doi: 10.1002/(sici)1097-4644(199702)64:23.0.co;2-f.
- Background: PubMed 9698003Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96. doi: 10.2106/00004623-199807000-00007.
- Background: PubMed 1870029Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
- Background: PubMed 7924141Caplan AI. The mesengenic process. Clin Plast Surg. 1994 Jul;21(3):429-35.
- Background: PubMed 16144456Caplan AI. Review: mesenchymal stem cells: cell-based reconstructive therapy in orthopedics. Tissue Eng. 2005 Jul-Aug;11(7-8):1198-211. doi: 10.1089/ten.2005.11.1198.
- Background: PubMed 11205861Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM. Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Joint Surg Am. 2001 Jan;83(1):71-7. doi: 10.2106/00004623-200101000-00010.
- Background: PubMed 11741065Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.
- Background: PubMed 14960664Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
- Background: PubMed 16600252Gimbel JA, Van Kleunen JP, Lake SP, Williams GR, Soslowsky LJ. The role of repair tension on tendon to bone healing in an animal model of chronic rotator cuff tears. J Biomech. 2007;40(3):561-8. doi: 10.1016/j.jbiomech.2006.02.010. Epub 2006 Apr 4.
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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.
Benjamin Fernandez-Gutierrez, MD, PhD principal investigator
Hospital Universitario Clinico San Carlos
Pilar Tornero-Esteban, Bs, PhD study director
Hospital Universitario Clinico San Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stem Cells (MSCs) and OrthADAPT in people with Chronic Disease, run by Hospital San Carlos, Madrid 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 7 inclusion and 1 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 19 Sep 2012. 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. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamín Fernández-Gutiérrez, PhD (+34913303615 ext. 7803, bfernandez.hcsc@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Shoulder Score (time frame: up to 1 year). 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 NCT01687777, which also lists 26 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 19 Sep 2012.