BlueCross and BlueShield of Montana Medical Policy/Codes
Stem-Cell Therapy for Peripheral Arterial Disease (PAD)
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: August 01, 2012
Publish Date: October 25, 2013

Critical limb ischemia due to peripheral arterial disease (PAD) results in pain at rest, ulcers, and significant risk for limb loss. Injection of hematopoietic stem-cells concentrated from bone marrow is being evaluated for the treatment of critical limb ischemia when surgical or endovascular revascularization has failed.

PAD is a common atherosclerotic syndrome that is associated with significant morbidity and mortality. A less-common cause of PAD is Buerger disease, also called thromboangiitis obliterans, which is a nonatherosclerotic segmental inflammatory disease that occurs in younger patients and is associated with tobacco use. Development of PAD is characterized by narrowing and occlusion of arterial vessels and eventual reduction in distal perfusion. The standard therapy for severe, limb-threatening ischemia is revascularization aiming to improve blood flow to the affected extremity. If revascularization has failed or is not possible, amputation is often necessary.

Two endogenous compensating mechanisms may occur with occlusion of arterial vessels, capillary growth (angiogenesis) and development of collateral arterial vessels (arteriogenesis). Capillary growth is mediated by hypoxia-induced release of chemo- and cytokines such as vascular endothelial growth factor (VEGF), and occurs by sprouting of small endothelial tubes from pre-existing capillary beds. The resulting capillaries are small and cannot sufficiently compensate for a large occluded artery. Arteriogenesis with collateral growth is, in contrast, initiated by increasing shear forces against vessel walls when blood flow is redirected from the occluded transport artery to the small collateral branches, leading to an increase in the diameter of pre-existing collateral arterioles.

The mechanism underlying arteriogenesis includes the migration of bone marrow-derived monocytes to the perivascular space. The bone marrow derived monocytes adhere to and invade the collateral vessel wall. It is not known if the expansion of the collateral arteriole is due to the incorporation of stem-cells into the wall of the vessel or to cytokines released by monocytic bone marrow cells that induce the proliferation of resident endothelial cells. It has been proposed that bone marrow derived monocytic cells may be the putative circulating endothelial progenitor cells. Notably, the same risk factors for advanced ischemia (diabetes, smoking, hyperlipidemia and advanced age) are also risk factors for a lower number of circulating progenitor cells.

The rationale of hematopoietic stem-cell or bone marrow cell therapy in PAD is to induce arteriogenesis by boosting the physiological repair processes. This requires large numbers of functionally active precursor cells, and subsequently a large quantity of bone marrow (e.g., 240-500 mL).

Standard outcomes for critical limb ischemia include the Rutherford criteria for limb status, healing of ulcers, the ankle-brachial index (ABI), transcutaneous oxygen pressure (TcO2), and pain-free walking. The Rutherford criteria include ankle and toe pressure, the level of claudication, ischemic rest pain, tissue loss, nonhealing ulcer, and gangrene. The ABI measures arterial segmental pressures on the ankle and brachium, and indexes ankle systolic pressure against brachial systolic pressure (normal range 0.95 – 1.2). An increase > 0.1 is considered to be clinically significant. TcO2 is measured with an oxymonitor; the normal value is 70-90 mmHg. Pain free walking may be measured by time on a treadmill, or more frequently by distance in a 400 meter walk.

Regulatory Status

The SmartPReP2® Bone Marrow Aspirate Concentrate System (Harvest Technologies) is a microprocessor-controlled dedicated centrifuge with decanting capability and an accessory BMAC IDE PAD Pack for processing a patient’s bone marrow aspirate and has been developed as a single-step point-of-care, bedside centrifugation system for the concentration of stem-cells from bone marrow. The system is composed of a portable centrifuge and an accessory pack that contains processing kits including a functionally closed dual-chamber sterile processing disposable. The SmartPReP2 system is designed to concentrate a buffy coat of 20 mL from whole bone marrow aspirate of 120 mL. The concentrate of bone marrow aspirate contains a mix of cell types, including lymphocytoid cells, erythroblasts, monocytoid cells, and granulocytes. Following isolation and concentration, the hematopoietic stem-cell or bone marrow concentrate is administered either intra-arterially or through multiple injections (20 to 60) into the muscle, typically in the gastrocnemius. The system is in a Phase III trial; expected completion of the trial is in 2014. As far as the U.S. Food and Drug Administration (FDA) approvals, the SmartPReP2 system was approved to market as a centrifuge for clinical use in September 2005. The intended use was for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.


Blue Cross Blue Shield of Montana (BCBSMT) considers stem-cell therapy, including injection or infusion of cells concentrated from bone marrow aspirate, experimental, investigational and unproven as a treatment of peripheral arterial disease (PAD), including critical limb ischemia.


The investigation of stem-cell therapy use for the treatment of peripheral arterial disease (PAD) has been identified through a literature search. The literature included recent review articles, consisting of case series and controlled studies. (1, 2)

Randomized Controlled Trials

In 2010, Prochazka and colleagues reported a randomized study of 96 patients with critical limb ischemia and foot ulcer. (3) Patient inclusion criteria were critical limb ischemia as defined by ABI <0.4, ankle systolic pressure <50 mmHg or toe systolic pressure <30 mmHg, and failure of basic conservative and revascularization treatment (surgical or endovascular). The patients were randomized into treatment with bone marrow concentrate (n=42) or standard medical care (n=54). The primary endpoints were major limb amputation during 120 days and degree of pain and function at 90- and 120-day follow-up. At baseline, the control group had a higher proportion of patients with diabetes (98.2% vs. 88.1%), hyperlipidemia (80.0% vs. 54.8%) and ischemic heart disease (76.4% vs. 57.1%). In addition, the control group had a higher proportion of patients with stage DIII (deep ulcers with osteitis) University of Texas Wound Classification (72% vs. 40%). For the 42 patients in the treatment group, there was a history of 50 revascularization procedures; 46 of 54 patients in the control group had a history of revascularization procedures. Forty-two of the 42 patients in the bone-marrow group finished 90 days of follow-up and 37 of 54 patients in the control group finished 120 days of follow-up. The reason for different times of follow-up for the primary outcome measure is unclear. Five patients in the bone-marrow group and eight in the control group died of causes unrelated to the therapy during follow-up. At follow-up, the frequency of major limb amputation was 21% in patients treated with bone marrow concentrate and 44% in controls. Secondary endpoints were performed only in the group treated with bone marrow concentrate. In the treatment group with salvaged limbs, toe pressure and toe brachial index increased from 22.66 to 25.63 mmHg and from 0.14 to 0.17 mmHg, respectively. Interpretation of this study is limited by unequal baseline measures, lack of blinding, different periods of follow-up, different loss to follow-up and different measures at follow-up for the two groups.

In 2002, the Therapeutic Angiogenesis by Cell Transplantation (TACT) study investigators published results of a pilot study and a small double-masked trial with 22 patients who were treated with bone marrow-mononuclear cells by intramuscular injection into the gastrocnemius of one leg and peripheral blood-mononuclear cells in the other leg as a control (randomized order). (4) Patients qualified for marrow implantation if they had bilateral chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and were not candidates for nonsurgical or surgical revascularization. Seventeen patients (85%) had been previously treated with percutaneous angioplasty, bypass graft, or both. The patients had resting ankle-brachial index (ABI) < 0.6 in both limbs. Patients with poorly controlled diabetes mellitus or with evidence of malignant disorder during the past five years were excluded from the study. About 500 mL of bone marrow cells were aspirated from the ileum, separated, and concentrated to a final volume of about 30 mL. About 3 hours after marrow aspiration the cells were implanted by intramuscular injection into the gastrocnemius. Follow-up with ABI, transcutaneous oxygen pressure (TcO2) and pain-free walking time was performed every week for 4 weeks and every 4 months thereafter. Two patients discontinued the study after randomization due to clinical worsening before 4 weeks. At 4 weeks after treatment, ABI, TcO2, and rest pain were significantly improved in legs injected with bone marrow-mononuclear cells, compared with those injected with peripheral blood-mononuclear cells. For example, ABI increased by 0.1 in the leg treated with bone marrow-mononuclear cell and by 0.02 with peripheral blood-mononuclear cells. TcO2 improved by 17.4 mmHg with bone marrow-mononuclear cells and by 4.6 mmHg with peripheral blood-mononuclear cells. Rest pain in legs treated with bone marrow-mononuclear cells was resolved in 16 of 20 patients, while pain in legs treated with peripheral blood-mononuclear cells remained in 17 of 20 patients. These improvements were sustained at 24 week follow-up. Digital subtraction angiography showed a marked increase in the number of visible collateral vessels in 60% of legs treated with bone marrow cells. No adverse events were reported.

Uncontrolled Studies

The 2008 TACT report by the same multicenter group of investigators assessed the 3 year safety and clinical outcomes of intramuscular implantation of bone marrow-mononuclear cells in a series of 74 patients with critical limb ischemia due to atherosclerotic PAD and 41 patients with thromboangiitis obliterans (TAO; Buerger’s disease). (5) The ischemic limbs were not candidates for surgical or nonsurgical revascularization. Twenty-six patients (23%) had a previous bypass operation. Bone marrow cells were aspirated from the ileum, and the mononuclear cells sorted and concentrated to a final volume of 40 mL. The cells were implanted by intramuscular injection into the foot. Patients were followed every week for 3 weeks and at 6, 12, 24, and 36 months thereafter. The overall survival (OS), amputation-free interval, adverse events, ABI, TcO2, pain scale, ulcer size, and pain-free walking distance were evaluated at each time point. Overall patient survival and amputation-free interval were defined as the primary end points of this study. Three year OS rates were 80% in patients with atherosclerotic PAD and 100% for patients with TAO. The median follow-up time of surviving patients was 25 months (range, 0.8 to 69 months). The 3 year amputation-free rate was 60% in atherosclerotic PAD and 91% in patients with TAO. Of the 24 amputations in patients with PAD, 83% occurred within 6 months. Multivariate analysis indicated that the severity of ischemic pain at baseline and prior repeated bypass surgery were the major determinants that negatively affected the amputation-free interval of the therapy. The ABI and TcO2 pressure value did not significantly change, but there was a significant improvement in the leg pain scale (from 6 to 2), ulcer size (from 3.5 cm2 to 0), and pain-free walking distance (from about 25 meters to 100 meters) at 6 months.

Aman et al. reported a pilot study of autologous bone marrow cell transplantation in 51 consecutive patients with impending major amputation due to end-stage critical limb ischemia in 2009. (6) Forty-five patients (88%) had undergone a mean of 2 unsuccessful attempts of operative and/or percutaneous revascularization of the ischemic limb. Six patients (12%) were technically not amenable to revascularization. Critical limb ischemia was confirmed if there was angiographic proof of arterial occlusion and one of the following criteria was fulfilled: ABI <0.6 or TcO2 <30 mmHg. Major amputation (above the ankle) had been recommended to 46 of the 51 patients (90%) by the treating vascular surgeons. For the first 12 subjects, 450-500 mL bone marrow was aspirated under general anesthesia and processed by the Ficoll method. For the remaining subjects, 240 mL bone marrow was aspirated under sedation and processed using an automated bedside density gradient centrifugation method. The final treating volume (55-85 mL) was adjusted with plasma depending on the area to be treated (whole leg, calf only, or foot), based on the localization and extent of the arterial occlusions. In addition, if a wound was present, 4-10 injections of bone marrow concentrate were given into the wound bed and the wound perimeter. Patients were seen monthly up to 6 months and at least in half-year intervals after. Minimum follow-up was 6 months, and the mean follow-up was 411 days (range 175 to 1186 days). No patients were lost to follow-up. Improvement in perfusion and subsequent limb salvage was achieved in 30/51 patients (59%) at 6 months and 27/51 (53%) at last follow-up (mean of 411 days). Seventeen minor amputations (6 forefoot and 11 toes) were performed in the 30 patients with 24-week limb salvage. Complete wound healing was achieved in 15 of 21 patients with ischemic wounds. Perfusion, measured at 6 months with ABI and TcO2, increased in patients with limb salvage and did not change in patients who eventually underwent major amputation. Patients with limb salvage improved from a mean Rutherford category of 4.9 at baseline to 3.3 at six months. Analgesic consumption was reduced by 62%. Total walking distance improved in non-amputees from a median of 0 to 40 meters at 24 weeks. No unexpected long-term adverse events occurred.

Ongoing Clinical Trials

The design of the BONe Marrow Outcome Trial in Critical Limb Ischaemia (BONMOT-CLI) trial was reported in 2008. (7) It is an investigator-initiated, randomized, double-blinded, placebo-controlled multicenter study at 4 sites in Germany that assesses the therapeutic value of bone marrow cell-induced angiogenesis and arteriogenesis in severe, limb-threatening ischemia. Ninety patients with no option for revascularization or after failed revascularization will be randomized to 40 injections into the ischemic limb with a concentrate of autologous bone marrow cells or to sham bone marrow aspiration and 40 placebo injections. The combined primary endpoint is major amputation or persisting critical limb ischemia (no improvement) over three months. Secondary endpoints are death, changes in perfusion, quality of life, walking distance, minor amputations, wound healing, collateral density and cancer incidence. Post study follow-up is two years.

JUVENTAS (Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation) is a randomized, double-blind, placebo-controlled trial in the Netherlands. (8)  The clinical effects of repeated intra-arterial infusion of bone marrow mononuclear cells will be investigated in 110-160 patients with critical limb ischemia. Patients will receive repeated intra-arterial infusion of bone marrow-mononuclear cells or placebo into the common femoral artery. The primary outcome measure is the rate of major amputation after 6 months. Secondary endpoints include minor amputation, number and extent of leg ulcers, resolution of rest pain, perfusion, change in quality of life, and change in clinical status. Functional characteristics of the bone marrow-mononuclear cells will also be studied and the bone marrow-mononuclear cell dysfunction will be related to clinical outcome.

A search of in April 2011 identified a number of ongoing trials with hematopoietic stem-cell or bone marrow concentrate for PAD, including:

  • A manufacturer-sponsored U.S. multicenter Phase II study on the use of autologous bone marrow cells for the treatment of critical limb ischemia due to PAD (NCT00468000). The double-blind study is expected to enroll 150 patients, randomized into 2 patient groups. The treatment group will receive intramuscular injections of Aastrom Biosciences TRC autologous bone marrow cell product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). The estimated completion date is listed as March 2011.
  • A manufacturer-sponsored Phase III trial with bone marrow aspirate concentrate with the SmartPReP2® system for the treatment of critical limb ischemia (NCT01245335). This is a U.S. pivotal randomized double-blind safety and efficacy trial comparing bone marrow aspirate concentrate with placebo injection into ischemic tissue of the lower extremity in 210 patients. The study start date is listed as January 2011; the expected study completion date is June 2014.


Based on initial evidence from case series and small randomized trials, injection of bone marrow concentrate may hold promise as a treatment for critical limb ischemia due to PAD. However, well-designed and well-conducted randomized controlled trials are needed to evaluate the health outcomes of this procedure. A number of trials are in progress, including several large randomized double-blind placebo controlled trials. Results from these trials are needed to adequately evaluate the impact on net health outcome of this procedure. Further information on the safety and durability of the treatment is also needed. Therefore, infusion or injection of stem-cells (bone marrow concentrate) for PAD is considered experimental, investigational and unproven.

2013 Update

A search of peer reviewed literature was completed through February 2013. The following is the key literature to date.

Results from the multi-center PROVASA trial (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients with Peripheral Arterial Occlusive Disease) were reported in 2011. (9) In this double-blind Phase II trial, 40 patients with critical limb ischemia who were not candidates or had failed to respond to interventional or surgical procedures were randomized to intra-arterial administration of bone marrow-derived mononuclear cells (BM-MNC) or placebo. The cell suspension included hematopoietic, mesenchymal, and other progenitor cells. After 3 months, both groups were treated with BM-MNC in an open-label phase. Twelve patients received additional treatment with BM-MNC between 6 and 18 months. The primary outcome measure, a significant increase in the ABI at 3 months, was not achieved (from 0.66 at baseline to 0.75 at 3 months). Limb salvage and amputation-free survival rates did differ between the groups. There was a significant improvement in ulcer healing (ulcer area 1.89 cm2 vs. 2.89 cm2) and reduced pain at rest (improvement of about 3 vs. 0.05) following intra-arterial BM-MNC administration. This is the only randomized controlled trial to report intra-arterial administration of BM-MNC.

A search of online site in February 2013 identified a number of ongoing trials with hematopoietic stem-cell/bone marrow concentrate for peripheral arterial disease, including:

  • A manufacturer-sponsored U.S. multicenter Phase II study on the use of autologous bone marrow cells for the treatment of critical limb ischemia due to PAD (NCT00468000) was discussed above. The RESTORE-CLI study is now listed as completed (interim analysis from 46 patients was reported in 2011). (10)
  • A manufacturer-sponsored Phase III trial with bone marrow aspirate concentrate with the SmartPReP2® system for the treatment of critical limb ischemia (NCT01245335). This is a U.S. pivotal randomized double-blind safety and efficacy trial comparing bone marrow aspirate concentrate with placebo injection into ischemic tissue of the lower extremity in 210 patients. The study start date is listed as January 2011; the expected study completion date is June 2014.


Based on the search of peer reviewed literature, there was no additional information that would change the coverage position of this medical policy. Therefore treatment of PAD with infusion or injection of stem-cells (bone marrow concentrate) remains experimental, investigational and unproven.


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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

99.79, 440.20, 440.21, 440.22, 440.23, 440.24, 440.29, 440.4, 440.8, 440.9, 443.1, 443.9, 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19

ICD-10 Codes

E08.621, E09.621, I70.201, I70.202, I70.203, I70.208, I70.209, I70.211, I70.212, I70.213, I70.218, I70.219, I70.221, I70.222, I70.223, I70.228, I70.229, I70.231, I70.232, I70.233, I70.234, I70.235, II70.238, I70.239, I70.241, I70.242, I70.243, I70.244, I70.245, I70.248, I70.249, I70.25, I70.261, I70.262, I70.263, I70.268, I70.269, I70.291, I70.292, I70.293, I70.298, I70.299, I70.331, I70.332, I70.333, I70.334, I70.235, I70.338, I70.339, I70.341, I70.342, I70.343, I70.344, I70.345, I70.348, I70.349, I70.431, I70.432, I70.433, I70.434, I70.435, I70.438, I70.439, I70.441, I70.442, I70.443, I70.444, I70.445, I70.448, I70.449, I70.531, I70.532, I70.533, I70.534, I70.535, I70.538, I70.539, I70.541, I70.542, I70.543, I70.544, I70.545, I70.548, I70.549, I70.631, I70.632, I70.633, I70.634, I70.635, I70.638, I70.639, I70.641, I70.642, I70.643, I70.644, I70.645, I70.648, I70.649, I70.731, I70.732, I70.733, I70.734, I70.735, I70.738, I70.739, I70.741, I70.742, I70.743, I70.744, I70.745, I70.748, I70.749, I70.8, I70.90, I70.91, I70.92, I73.1, I73.9, L97.101, L97.102, L97.103, L97.104, L97.109, L97.111, L97.112, L97.113, L97.114, L97.119, L97.121, L97.122, L97.123, L97.124, L97.129, L97.201, L97.202, L97.203, L97.204, L97.209, L97.211, L97.212, L97.213, L97.214, L97.219, L97.221, L97.222, L97.223, L97.224, L97.229, L97.301, L97.302, L97.303, L97.304, L97.309, L97.311, L97.312, L97.313, L97.314, L97.319, L97.321, L97.322, L97.323, L97.324, L97.329,  L97.401, L97.402, L97.403, L97.404, L97.409, L97.411, L97.412, L97.413, L97.414, L97.419, L97.421, L97.422, L97.423, L97.424, L97.429, L97.501, L97.502, L97.503, L97.504, L97.509, L97.511, L97.512, L97.513, L97.514, L97.519, L97.521, L97.522, L97.523, L97.524, L97.529, L97.801, L97.802, L97.803, L97.804, L97.809, L97.811, L97.812, L97.813, L97.814, L97.819, L97.821, L97.822, L97.823, L97.824, L97.829, L97.901, L97.902, L97.903, L97.904, L97.909, L97.911, L97.912, L97.913, L97.914, L97.919, L97.921, L97.922, L97.923, L97.924, L97.929, 6A550ZT, 6A550ZV

Procedural Codes: 0263T, 0264T, 0265T
  1. Lawall, H., Bramlage, P., et al. Treatment of peripheral arterial disease using stem and progenitor cell therapy. Journal of Vascular Surgery (2011 February) 53(2):445-53.
  2. Fadini, G.P., Agostini, C., et al. Autologous stem-cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis (2010 March) 209(1):10-7.
  3. Prochazka, V., Gumulec, J., et al. Cell therapy, a new standard in management of chronic critical limb ischemia and foot ulcer. Cell Transplantation (2010) 19(11):1413-24.
  4. Tateishi-Yuyama, E., Matsubara, H., et al. Therapeutic angiogenesis for patients with limb ischemia by autologous transplantation of bone-marrow cells: a pilot study and a randomized controlled trial. Lancet (2002 August 10) 360(9331):427-35.
  5. Matoba, S., Tatsumi, T., et al. Long-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (Therapeutic Angiogenesis by Cell Transplantation [TACT] trial) in patients with chronic limb ischemia. American Heart Journal (2008 November) 156(5):1010-8.
  6. Amann, B., Luedemann, C., et al. Autologous bone marrow cell transplantation increases leg perfusion and reduces amputations in patients with advanced critical limb ischemia due to peripheral artery disease. Cell Transplantation (2009) 18(3):371-80.
  7. Amann, B., Ludemann, C., et al. Design and rationale of a randomized, double-blind, placebo-controlled phase III study for autologous bone marrow cell transplantation in critical limb ischemia: the BONe Marrow Outcomes Trial in Critical Limb Ischemia (BONMOT-CLI). Vasa (2008 November) 37(4):319-25.
  8. Sprengers, R.W., Moll, F.L., et al. Rationale and design of the JUENTAS trial for repeated intra-arterial infusion of autologous bone marrow-derived mononuclear cells in patients with criterial limb ischemia. Journal of Vascular Surgery (2010 June) 51(6):1564-8.
  9. Walter DH, Krankenberg H, Balzer JO et al. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circulation Cardiovascular interventions 2011; 4(1):26-37.
  10. Powell RJ, Comerota AJ, Berceli SA et al. Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia. J Vasc Surg 2011; 54(4):1032-41.
  11. Stem-Cell Therapy for Peripheral Arterial Disease. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 May) Therapy 8.01.55.
August 2012  Policy created with literature review through February 2012; considered investigational
October 2013 Policy formatting and language revised.  Policy statement unchanged.
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Stem-Cell Therapy for Peripheral Arterial Disease (PAD)