Peripheral Arterial DiseasePhase 1NCT02915796

Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty

A Phase 1 study testing G-CSF + CD133(+) cells, G-CSF and percutaneous transluminal angioplasty (PTA) in people with Peripheral Arterial Disease, run by Shanghai 10th People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK)… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: G-CSF + CD133(+) cells, G-CSF and percutaneous transluminal angioplasty (PTA)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 345 participants
Where: 1 siteChina
Study dates: Sep 2016to Apr 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age range: 18-75 years , Gender: Both
Patients with below the knee limb ischemia with diabetes.
Rutherford class 2-6.
Target lesions with a diameter reduction of at least 50% and have an occlusion of longer than 4 cm on angiography.
Have no previous history of any stem cell therapy [infusion of CD133 endothelial progenitor cell (EPC)].
Written informed consent signed by the patients or representatives. -

Who cannot join

Previous bypass surgery or stent placement at the ipsilateral lower limb
History of intolerance to antiplatelet therapy, heparin, or contrast media.
Presence of any of the following conditions:
severe liver disease (such as ascites, esophageal varices, liver transplantation);
hemodynamic instability;
Severely impaired renal function (serum creatinine level > 2.5 mg/dL).

Show all 11Show fewer

Receiving immunosuppressive therapy;
History of decompensated heart failure (New York Heart Association class III or IV and level) or myocardial infarction, or heart bypass surgery;
Bleeding diathesis;
Active systemic bacterial infection;
Acute thrombophlebitis or deep vein thrombosis of the target limb; 4) Pregnant or lactating women, or women of child bearing age unable or unwilling to use effective contraception during the study period; 5) Expected survival time of less than 24 months -

Trial locations and contacts

1 site in 1 country.

Mao Q Li, Ph.D contact

02166313506

cjr.limaoquan@vip.163.com

China1 site, 1 recruiting

Shanghai Tenth People's Hospital, Tong ji University
Shanghai
Mao Q Li, Ph.D, 02166313506, cjr.limaoquan@vip.163.com
Recruiting

Other trials in China

About this study

Official title: Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty: A Randomized Controlled Clinical Trial in Diabetic Patients With Below the Knee Critical Limb Ischemia

Read the detailed description

CD133+ cell, a bone marrow derived subpopulation of adult hematopoietic progenitor cells, confers high proliferative, vasculogenic and regenerative capacity in vitro and in vivo. thereby suggesting that CD133+ cells may induce vasculogenesis, improve limb perfusion, prevent tissue loss and restore ambulatory function in patients with critical limb ischemia. Although several small, randomized trials have been conducted so far demonstrating safety of autologous cells of bone marrow origin for the treatment, the reported benefits were found to be variable. A meta-analysis of autologous bone marrow derived cell therapy for critical limb ischemia trials suggested that application of autologous stem cell transplantation in curing limb ischemic patients does not have obviously effectiveness in the improvement of ankle brachial pressure (ABI) of the limb ischemic patients. But it can dramatically reduce the rate of amputation.

Therefore, in the present study, the investigators aim to evaluate the therapeutic potential and safety of transarterial infusion of g-csf-mobilized CD 133(+) cells when combined with PTA in treatment of below the knee PAD in diabetic patients.

Conditions: Peripheral Arterial Disease
Being tested: G-CSF + CD133(+) cells, G-CSF, percutaneous transluminal angioplasty (PTA), Placebo infusion
Keywords: Endothelial progenitor cell, Percutaneous transluminal angioplasty
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

G-CSF + CD133(+) cellsBiological
Patients in the G-CSF + CD133(+) cells + PTA group, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize CD 133 cells from bone marrow to peripheral blood. After 72-120 hrs, 100 ml suspension of peripheral arterial blood were collected and send to Good Products Manufacturing (GPM) certified laboratory (Shanghai Chen Chuan Biological Material Co. Ltd.) within 24 hrs of obtaining sample to isolate CD 133(+) endothelial progenitor cells (EPC) using magnetic cell separator. Subjects in this group, after vascular PTA treatment, received transarterial infusion of 50 ml suspension of isolated autologous CD 133(+) cells over 30 min via catheter opened into popliteal artery. The infusion of CD 133 cells was repeated after 24 hours.
G-CSFBiological
Subjects in this group, after vascular PTA treatment, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize EPCs from bone marrow to peripheral blood. But the C133 (+) cells were not isolated from the peripheral blood to infuse transarterially as in G-CSF + CD133(+) + PTA.
percutaneous transluminal angioplasty (PTA)Procedure or surgery
Subjects in this group only underwent below the knee percutaneous transluminal angioplasty .
Placebo infusionBiological
Neither G-CSF was injected nor CD133(+) cells. Instead, subjects received placebo infusion (50 ml of 0.9% sodium chloride injection ) over 30 min.

Study groups in NCT02915796
Study group	Role	What they receive
G-CSF + CD133(+) cells + PTA	Experimental	Intramuscular injection of G-CSF along with transarterial infusion of CD133 (+) cells combined with percutaneous transluminal angioplasty Receives: Biological: G-CSF + CD133(+) cells; Procedure: percutaneous transluminal angioplasty (PTA)
PTA + G-CSF	Active comparator	Percutaneous transluminal angioplasty along with intramuscular injection of G-CSF Receives: Biological: G-CSF; Procedure: percutaneous transluminal angioplasty (PTA)
Only PTA	Placebo comparator	Only Percutaneous transluminal angioplasty along with placebo infusion of sodium chloride injection Receives: Procedure: percutaneous transluminal angioplasty (PTA); Biological: Placebo infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Restenosis rate
Occurrence of > 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA) (Efficacy endpoints).
Measured: 12 months
Peak systolic velocity ratio
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography for patients who did not undergo angiography after 12 months (Efficacy endpoints).
Measured: 12 months
Severe adverse effects (SAEs)
Number of SAEs per subject across actual treatment cohorts (Safety Endpoint).
Measured: 12 months

Secondary outcomes (7)

ABI value
Improvement in ABI value by ≥ 0.1 after the procedure and lack of deterioration > 0.15 in relation to the maximal value recorded before the procedure.
Measured: 6 and 12 months
Rutherford classification
improvement in Rutherford scale of at least one category after the procedure.
Measured: 6 and 12 months
Transcutaneous oxygen pressures (TcPO2)
.Changes in TcPO2 was assessed at each follow up interval and compared to baseline.
Measured: 6 and 12 months
Amputation-free survival (AFS)
Time to below the knee amputation of the ipsilateral leg.
Measured: 6 and 12 months
Rest pain
Rest pain was measured using Wong-Baker FACES pain rating scale at baseline and each follow-up visit.
Measured: 6 and 12 months
Six Minute Walk test
Walking distance, time to onset of leg cramping/pain were recorded.
Measured: 6 and 12 months
Ulcer healing rate
Ulcer status was assessed at each follow up interval and compared to baseline.
Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Apr 2018

First posted27 Sep 2016 (estimated)
Study startSep 2016
Primary completionApr 2017 (estimated)
Study completionApr 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 345 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02915796
Sponsor's protocol ID: 2016-xjs-08
Status last verified: Sep 2016
First submitted: 22 Sep 2016
Last updated: 28 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Ma N, Ladilov Y, Moebius JM, Ong L, Piechaczek C, David A, Kaminski A, Choi YH, Li W, Egger D, Stamm C, Steinhoff G. Intramyocardial delivery of human CD133+ cells in a SCID mouse cryoinjury model: Bone marrow vs. cord blood-derived cells. Cardiovasc Res. 2006 Jul 1;71(1):158-69. doi: 10.1016/j.cardiores.2006.03.020. Epub 2006 Apr 3.
PubMed 16730684
Gehling UM, Ergun S, Schumacher U, Wagener C, Pantel K, Otte M, Schuch G, Schafhausen P, Mende T, Kilic N, Kluge K, Schafer B, Hossfeld DK, Fiedler W. In vitro differentiation of endothelial cells from AC133-positive progenitor cells. Blood. 2000 May 15;95(10):3106-12.
PubMed 10807776
Peichev M, Naiyer AJ, Pereira D, Zhu Z, Lane WJ, Williams M, Oz MC, Hicklin DJ, Witte L, Moore MA, Rafii S. Expression of VEGFR-2 and AC133 by circulating human CD34(+) cells identifies a population of functional endothelial precursors. Blood. 2000 Feb 1;95(3):952-8.
PubMed 10648408
Friedrich EB, Walenta K, Scharlau J, Nickenig G, Werner N. CD34-/CD133+/VEGFR-2+ endothelial progenitor cell subpopulation with potent vasoregenerative capacities. Circ Res. 2006 Feb 17;98(3):e20-5. doi: 10.1161/01.RES.0000205765.28940.93. Epub 2006 Jan 26.
PubMed 16439688
Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
PubMed 12241713
Esato K, Hamano K, Li TS, Furutani A, Seyama A, Takenaka H, Zempo N. Neovascularization induced by autologous bone marrow cell implantation in peripheral arterial disease. Cell Transplant. 2002;11(8):747-52.
PubMed 12588106
Fadini GP, Avogaro A. Autologous transplantation of granulocyte colony-stimulating factor- mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2006 Feb;29(2):478-9; author reply 479-80. doi: 10.2337/diacare.29.02.06.dc05-1770. No abstract available.
PubMed 16482702
Miyamoto K, Nishigami K, Nagaya N, Akutsu K, Chiku M, Kamei M, Soma T, Miyata S, Higashi M, Tanaka R, Nakatani T, Nonogi H, Takeshita S. Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans. Circulation. 2006 Dec 12;114(24):2679-84. doi: 10.1161/CIRCULATIONAHA.106.644203. Epub 2006 Dec 4.
PubMed 17145986
Kawamoto A, Katayama M, Handa N, Kinoshita M, Takano H, Horii M, Sadamoto K, Yokoyama A, Yamanaka T, Onodera R, Kuroda A, Baba R, Kaneko Y, Tsukie T, Kurimoto Y, Okada Y, Kihara Y, Morioka S, Fukushima M, Asahara T. Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells. 2009 Nov;27(11):2857-64. doi: 10.1002/stem.207.
PubMed 19711453
Lu D, Chen B, Liang Z, Deng W, Jiang Y, Li S, Xu J, Wu Q, Zhang Z, Xie B, Chen S. Comparison of bone marrow mesenchymal stem cells with bone marrow-derived mononuclear cells for treatment of diabetic critical limb ischemia and foot ulcer: a double-blind, randomized, controlled trial. Diabetes Res Clin Pract. 2011 Apr;92(1):26-36. doi: 10.1016/j.diabres.2010.12.010. Epub 2011 Jan 8.
PubMed 21216483
Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.
PubMed 23192920
Sun X, Ying J, Wang Y, Li W, Wu Y, Yao B, Liu Y, Gao H, Zhang X. Meta-analysis on autologous stem cell transplantation in the treatment of limb ischemic. Int J Clin Exp Med. 2015 Jun 15;8(6):8740-8. eCollection 2015.
PubMed 26309525

Want to know more?

Mao Q Li, Ph.D

02166313506

cjr.limaoquan@vip.163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty: A Randomized Controlled Clinical Trial in Diabetic Patients With Below the Knee Critical Limb Ischemia
ClinicalTrials.gov ID: NCT02915796
Acronym / sponsor ID: 2016-xjs-08
Conditions: Peripheral Arterial Disease
Keywords: Endothelial progenitor cell, Percutaneous transluminal angioplasty
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 345 participants (estimated)
Lead sponsor: Shanghai 10th People's HospitalUniversity, hospital or other
Study start: Sep 2016
Primary completion: Apr 2017 (estimated)
Study completion: Apr 2018 (estimated)
First posted: 27 Sep 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
G-CSF + CD133(+) cells + PTA	Experimental	Biological: G-CSF + CD133(+) cells, Procedure: percutaneous transluminal angioplasty (PTA)Intramuscular injection of G-CSF along with transarterial infusion of CD133 (+) cells combined with percutaneous transluminal angioplasty
PTA + G-CSF	Active comparator	Biological: G-CSF, Procedure: percutaneous transluminal angioplasty (PTA)Percutaneous transluminal angioplasty along with intramuscular injection of G-CSF
Only PTA	Placebo comparator	Procedure: percutaneous transluminal angioplasty (PTA), Biological: Placebo infusionOnly Percutaneous transluminal angioplasty along with placebo infusion of sodium chloride injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age range: 18-75 years , Gender: Both
Patients with below the knee limb ischemia with diabetes.
Rutherford class 2-6.
Target lesions with a diameter reduction of at least 50% and have an occlusion of longer than 4 cm on angiography.
Have no previous history of any stem cell therapy [infusion of CD133 endothelial progenitor cell (EPC)].

Key exclusion criteria (11 listed)

Previous bypass surgery or stent placement at the ipsilateral lower limb
History of intolerance to antiplatelet therapy, heparin, or contrast media.
Presence of any of the following conditions:

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
G-CSF + CD133(+) cellsPatients in the G-CSF + CD133(+) cells + PTA group, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize CD 133 cells from bone marrow to peripheral blood. After 72-120 hrs, 100 ml suspension of peripheral arterial blood were collected and send to Good Products Manufacturing (GPM) certified laboratory (Shanghai Chen Chuan Biological Material Co. Ltd.) within 24 hrs of obtaining sample to isolate CD 133(+) endothelial progenitor cells (EPC) using magnetic cell separator. Subjects in this group, after vascular PTA treatment, received transarterial infusion of 50 ml suspension of isolated autologous CD 133(+) cells over 30 min via catheter opened into popliteal artery. The infusion of CD 133 cells was repeated after 24 hours.	Biological	G-CSF + CD133(+) cells + PTA
G-CSFSubjects in this group, after vascular PTA treatment, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize EPCs from bone marrow to peripheral blood. But the C133 (+) cells were not isolated from the peripheral blood to infuse transarterially as in G-CSF + CD133(+) + PTA.	Biological	PTA + G-CSF
percutaneous transluminal angioplasty (PTA)Subjects in this group only underwent below the knee percutaneous transluminal angioplasty .	Procedure or surgery	G-CSF + CD133(+) cells + PTA, Only PTA, PTA + G-CSF
Placebo infusionNeither G-CSF was injected nor CD133(+) cells. Instead, subjects received placebo infusion (50 ml of 0.9% sodium chloride injection ) over 30 min.	Biological	Only PTA

Primary outcome

Restenosis rate
Time frame: 12 months
Occurrence of > 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA) (Efficacy endpoints).
Peak systolic velocity ratio
Time frame: 12 months
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography for patients who did not undergo angiography after 12 months (Efficacy endpoints).
Severe adverse effects (SAEs)
Time frame: 12 months
Number of SAEs per subject across actual treatment cohorts (Safety Endpoint).

7 secondary outcomes

ABI value
Time frame: 6 and 12 months
Rutherford classification
Time frame: 6 and 12 months
Transcutaneous oxygen pressures (TcPO2)
Time frame: 6 and 12 months
Amputation-free survival (AFS)
Time frame: 6 and 12 months
Rest pain
Time frame: 6 and 12 months
Six Minute Walk test
Time frame: 6 and 12 months
Ulcer healing rate
Time frame: 6 and 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
Background: PubMed 16730684Ma N, Ladilov Y, Moebius JM, Ong L, Piechaczek C, David A, Kaminski A, Choi YH, Li W, Egger D, Stamm C, Steinhoff G. Intramyocardial delivery of human CD133+ cells in a SCID mouse cryoinjury model: Bone marrow vs. cord blood-derived cells. Cardiovasc Res. 2006 Jul 1;71(1):158-69. doi: 10.1016/j.cardiores.2006.03.020. Epub 2006 Apr 3.
Background: PubMed 10807776Gehling UM, Ergun S, Schumacher U, Wagener C, Pantel K, Otte M, Schuch G, Schafhausen P, Mende T, Kilic N, Kluge K, Schafer B, Hossfeld DK, Fiedler W. In vitro differentiation of endothelial cells from AC133-positive progenitor cells. Blood. 2000 May 15;95(10):3106-12.
Background: PubMed 10648408Peichev M, Naiyer AJ, Pereira D, Zhu Z, Lane WJ, Williams M, Oz MC, Hicklin DJ, Witte L, Moore MA, Rafii S. Expression of VEGFR-2 and AC133 by circulating human CD34(+) cells identifies a population of functional endothelial precursors. Blood. 2000 Feb 1;95(3):952-8.
Background: PubMed 16439688Friedrich EB, Walenta K, Scharlau J, Nickenig G, Werner N. CD34-/CD133+/VEGFR-2+ endothelial progenitor cell subpopulation with potent vasoregenerative capacities. Circ Res. 2006 Feb 17;98(3):e20-5. doi: 10.1161/01.RES.0000205765.28940.93. Epub 2006 Jan 26.
Background: PubMed 12241713Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
Background: PubMed 12588106Esato K, Hamano K, Li TS, Furutani A, Seyama A, Takenaka H, Zempo N. Neovascularization induced by autologous bone marrow cell implantation in peripheral arterial disease. Cell Transplant. 2002;11(8):747-52.
Background: PubMed 16482702Fadini GP, Avogaro A. Autologous transplantation of granulocyte colony-stimulating factor- mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2006 Feb;29(2):478-9; author reply 479-80. doi: 10.2337/diacare.29.02.06.dc05-1770. No abstract available.
Background: PubMed 17145986Miyamoto K, Nishigami K, Nagaya N, Akutsu K, Chiku M, Kamei M, Soma T, Miyata S, Higashi M, Tanaka R, Nakatani T, Nonogi H, Takeshita S. Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans. Circulation. 2006 Dec 12;114(24):2679-84. doi: 10.1161/CIRCULATIONAHA.106.644203. Epub 2006 Dec 4.
Background: PubMed 19711453Kawamoto A, Katayama M, Handa N, Kinoshita M, Takano H, Horii M, Sadamoto K, Yokoyama A, Yamanaka T, Onodera R, Kuroda A, Baba R, Kaneko Y, Tsukie T, Kurimoto Y, Okada Y, Kihara Y, Morioka S, Fukushima M, Asahara T. Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells. 2009 Nov;27(11):2857-64. doi: 10.1002/stem.207.
Background: PubMed 21216483Lu D, Chen B, Liang Z, Deng W, Jiang Y, Li S, Xu J, Wu Q, Zhang Z, Xie B, Chen S. Comparison of bone marrow mesenchymal stem cells with bone marrow-derived mononuclear cells for treatment of diabetic critical limb ischemia and foot ulcer: a double-blind, randomized, controlled trial. Diabetes Res Clin Pract. 2011 Apr;92(1):26-36. doi: 10.1016/j.diabres.2010.12.010. Epub 2011 Jan 8.
Background: PubMed 23192920Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.
Background: PubMed 26309525Sun X, Ying J, Wang Y, Li W, Wu Y, Yao B, Liu Y, Gao H, Zhang X. Meta-analysis on autologous stem cell transplantation in the treatment of limb ischemic. Int J Clin Exp Med. 2015 Jun 15;8(6):8740-8. eCollection 2015.
Individual participant dataSharing planned: No

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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.

Mao Q Li, Ph.D contact

02166313506

cjr.limaoquan@vip.163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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 28 Sep 2016. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mao Q Li, Ph.D (02166313506, cjr.limaoquan@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Restenosis rate (time frame: 12 months). The study lists 3 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 NCT02915796, which also lists 12 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 28 Sep 2016.