LymphedemaPhase 1/2SCLNCT01112189
Use of Stem Cells in Lymphedema Post Mastectomy
A Phase 1/2 study testing Autologous transplant and Compressed sleeve treatment in people with Lymphedema and Breast Cancer, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the most common complication of all attributable to mastectomy with axillary dissection and which occurs in one third of patients who undergo… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Autologous transplant and Compressed sleeve treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2009to Sep 2010
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with postsurgical lymphedema in upper extremities following axillary lymphadenectomy.
- Female gender.
- Age over 18 years.
- Patients who wish to participate in the study.
- Informed consent signed.
Who cannot join
- Patients with hypercoagulable states.
- Patients with a history of obstructive vascular disease in the brain, kidneys or heart.
- Patients with congestive heart failure (ejection fraction less than 30%)
- Active infectious process, serious, anywhere in the body.
- Patients over 75 years of age.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64810
About this study
Official title: Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the most common complication of all attributable to mastectomy with axillary dissection and which occurs in one third of patients who undergo radical mastectomy and radiotherapy post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of compression stockings, the use of pneumatic compression pumps and physiotherapy.
Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into various cell lines, reproduced and participate in neoangiogenesis. This study was conducted in the General Surgery Service, of the Hospital Universitario "Dr. José Eleuterio González "and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of postoperative lymphedema in upper limb following axillary lymphadenectomy through the stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over 18 years after axillary lymphadenectomy. The objective is to develop an innovative and definitive treatment for these patients and to analyze the costs and complications that this treatment may have.
Read the detailed description
Phase 1:
The procedure will be as follows:
10 patients were recruited in the General Surgery or Oncology meeting the inclusion criteria. During the study, patients can´t use any other kind of treatment for the lymphedema.
Visit 1: We explain the procedure by inviting patients to participate after signing informed consent. There will be a complete medical history, review of inclusion and exclusion criteria, signing a letter of informed consent, be requested general laboratory tests (blood count, biochemical profile), tele-ray.
Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for 3 consecutive days.
Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ® rpm/15 minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell layer. Once the cells were obtained will be transported to the operating room to manage the patient by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb with a depth of about one centimeter, using a needle number 25. The administration will take place in the operating room under local anesthesia or sedation if necessary.
Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest revision will be made and carried out measurements in both arms to conclude and determine the outcome of treatment.
Phase 2 (Control group):
Another 10 patients with lymphedema will be included in a 6 week study to compare the most common treatment of the lymphedema, the compressed sleeves.
Visit 1: A complete medical history will be performed. A compression sleeve will be given to the patients for their use during the next 2 weeks.
Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be measured in both upper extremities as well as assess the symptoms or not that patients present.
Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2 weeks measured both upper extremities and interrogate patients about symptoms during this period.
Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the compressed sleeves treatment and measured both upper extremities and interrogate patients about symptoms presented during this stage of the study.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Autologous transplant, Compressed sleeve treatment
- Keywords
- Lymphedema, Stem cells, Mastectomy, Breast Cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous transplantProcedure or surgery
Also called Stem Cells transplant
Patients will be stimulated 3 days with Filgrastrim 300 micrograms per day. On the 4th day the autologous transplant of stem cells will be performed.
Compressed sleeve treatmentOther
Also called Compressive sleeve treatment
Week 1-2: With compressed sleeve treatment.
Week 3 -4: Without treatment.
Week 5 - 6: With compressed sleeve treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with stem cells | Experimental | Patients that receive the stem cells treatment Receives: Procedure: Autologous transplant |
| Compressed sleeve treatment | Active comparator | Patients that will receive the compressed sleeve treatment Receives: Other: Compressed sleeve treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology.
Patients will be measured in 4 different areas of both arms with a tape measure, before the transplant and weekly after the transplant for 3 months.
Measure 1: 10 cm over the epicondyle. Measure 2: 5 cm over the the epicondyle. Measure 3: 5 cm under the the epicondyle. Measure 4: 15 cm under the the epicondyle Also a questionnaire of the most common symptoms will be given to the patients to mark their own symptoms before the transplant and 3 months after the transplant.
Measured: 3 months
Secondary outcomes (1)
Participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Investigators
- Gerardo E. Muñoz Maldonado, MD, Principal investigator, Hospital Universitario Dr Jose Eleuterio Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112189
- Sponsor's protocol ID
- CG08-005
- Acronym
- SCL
- Status last verified
- Feb 2010
- First submitted
- 20 Apr 2010
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomas-MacLean R, Miedema B, Tatemichi SR. Breast cancer-related lymphedema: women's experiences with an underestimated condition. Can Fam Physician. 2005 Feb;51(2):246-7.
PubMed 16926934Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: adjuvant systemic therapy for node-positive breast cancer (summary of the 2001 update). The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 2001 Mar 6;164(5):644-6. No abstract available.
PubMed 11258212Bumpers HL, Best IM, Norman D, Weaver WL. Debilitating lymphedema of the upper extremity after treatment of breast cancer. Am J Clin Oncol. 2002 Aug;25(4):365-7. doi: 10.1097/00000421-200208000-00009.
PubMed 12151966Kim H, Dumont DJ. Molecular mechanisms in lymphangiogenesis: model systems and implications in human disease. Clin Genet. 2003 Oct;64(4):282-92. doi: 10.1034/j.1399-0004.2003.00152.x.
PubMed 12974730Maldonado GE, Perez CA, Covarrubias EE, Cabriales SA, Leyva LA, Perez JC, Almaguer DG. Autologous stem cells for the treatment of post-mastectomy lymphedema: a pilot study. Cytotherapy. 2011 Nov;13(10):1249-55. doi: 10.3109/14653249.2011.594791.
PubMed 21999374
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)
- ClinicalTrials.gov ID
- NCT01112189
- Acronym / sponsor ID
- SCL / CG08-005
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Lymphedema, Stem cells, Mastectomy, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Apr 2010 (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.
The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the most common complication of all attributable to mastectomy with axillary dissection and which occurs in one third of patients who undergo radical mastectomy and radiotherapy post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of compression stockings, the use of pneumatic compression pumps and physiotherapy.
Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into various cell lines, reproduced and participate in neoangiogenesis. This study was conducted in the General Surgery Service, of the Hospital Universitario "Dr. José Eleuterio González "and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of postoperative lymphedema in upper limb following axillary lymphadenectomy through the stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over 18 years after axillary lymphadenectomy. The objective is to develop an innovative and definitive treatment for these patients and to analyze the costs and complications that this treatment may have.
Detailed description
Phase 1:
The procedure will be as follows:
10 patients were recruited in the General Surgery or Oncology meeting the inclusion criteria. During the study, patients can´t use any other kind of treatment for the lymphedema.
Visit 1: We explain the procedure by inviting patients to participate after signing informed consent. There will be a complete medical history, review of inclusion and exclusion criteria, signing a letter of informed consent, be requested general laboratory tests (blood count, biochemical profile), tele-ray.
Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for 3 consecutive days.
Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ® rpm/15 minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell layer. Once the cells were obtained will be transported to the operating room to manage the patient by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb with a depth of about one centimeter, using a needle number 25. The administration will take place in the operating room under local anesthesia or sedation if necessary.
Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest revision will be made and carried out measurements in both arms to conclude and determine the outcome of treatment.
Phase 2 (Control group):
Another 10 patients with lymphedema will be included in a 6 week study to compare the most common treatment of the lymphedema, the compressed sleeves.
Visit 1: A complete medical history will be performed. A compression sleeve will be given to the patients for their use during the next 2 weeks.
Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be measured in both upper extremities as well as assess the symptoms or not that patients present.
Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2 weeks measured both upper extremities and interrogate patients about symptoms during this period.
Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the compressed sleeves treatment and measured both upper extremities and interrogate patients about symptoms presented during this stage of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stem cells | Experimental | Procedure: Autologous transplantPatients that receive the stem cells treatment |
| Compressed sleeve treatment | Active comparator | Other: Compressed sleeve treatmentPatients that will receive the compressed sleeve treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with postsurgical lymphedema in upper extremities following axillary lymphadenectomy.
- Female gender.
- Age over 18 years.
- Patients who wish to participate in the study.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Patients with hypercoagulable states.
- Patients with a history of obstructive vascular disease in the brain, kidneys or heart.
- Patients with congestive heart failure (ejection fraction less than 30%)
- Active infectious process, serious, anywhere in the body.
- Patients over 75 years of age.
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 |
|---|---|---|
| Autologous transplantAlso: Stem Cells transplantPatients will be stimulated 3 days with Filgrastrim 300 micrograms per day. On the 4th day the autologous transplant of stem cells will be performed. | Procedure or surgery | Patients with stem cells |
| Compressed sleeve treatmentAlso: Compressive sleeve treatmentWeek 1-2: With compressed sleeve treatment. Week 3 -4: Without treatment. Week 5 - 6: With compressed sleeve treatment | Other | Compressed sleeve treatment |
Primary outcome
Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology.
Time frame: 3 months
Patients will be measured in 4 different areas of both arms with a tape measure, before the transplant and weekly after the transplant for 3 months. Measure 1: 10 cm over the epicondyle. Measure 2: 5 cm over the the epicondyle. Measure 3: 5 cm under the the epicondyle. Measure 4: 15 cm under the the epicondyle Also a questionnaire of the most common symptoms will be given to the patients to mark their own symptoms before the transplant and 3 months after the transplant.
1 secondary outcome
Participants with Adverse Events as a Measure of Safety and Tolerability.
Time frame: 3 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 Mar 2011.
- Background: PubMed 16926934Thomas-MacLean R, Miedema B, Tatemichi SR. Breast cancer-related lymphedema: women's experiences with an underestimated condition. Can Fam Physician. 2005 Feb;51(2):246-7.
- Background: PubMed 11258212Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: adjuvant systemic therapy for node-positive breast cancer (summary of the 2001 update). The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. CMAJ. 2001 Mar 6;164(5):644-6. No abstract available.
- Background: PubMed 12151966Bumpers HL, Best IM, Norman D, Weaver WL. Debilitating lymphedema of the upper extremity after treatment of breast cancer. Am J Clin Oncol. 2002 Aug;25(4):365-7. doi: 10.1097/00000421-200208000-00009.
- Background: PubMed 12974730Kim H, Dumont DJ. Molecular mechanisms in lymphangiogenesis: model systems and implications in human disease. Clin Genet. 2003 Oct;64(4):282-92. doi: 10.1034/j.1399-0004.2003.00152.x.
- Derived from this study: PubMed 21999374Maldonado GE, Perez CA, Covarrubias EE, Cabriales SA, Leyva LA, Perez JC, Almaguer DG. Autologous stem cells for the treatment of post-mastectomy lymphedema: a pilot study. Cytotherapy. 2011 Nov;13(10):1249-55. doi: 10.3109/14653249.2011.594791.
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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.
Gerardo E. Muñoz Maldonado, MD principal investigator
Hospital Universitario Dr Jose Eleuterio Gonzalez
1 site 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 Autologous transplant and Compressed sleeve treatment in people with Lymphedema and Breast Cancer, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site 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 5 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 24 Mar 2011. 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 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 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?
Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology. (time frame: 3 months). 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 NCT01112189, which also lists 5 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 Mar 2011.