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Status unknownNCT01152411Updated Mar 29, 2012

Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure

A Phase 1/2 interventional study of Autologous bone marrow stem cells in Chronic Renal Failure, sponsored by International Stemcell Services Limited. Status unknown at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-29.

Sponsored by International Stemcell Services Limited · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum.

CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery).

In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health.

In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.

02

Conditions studied

  • Chronic Renal Failure

Keywords

  • Renal Failure
  • Chronic Kidney Disease
  • Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's planned enrollment of 5 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

International Stemcell Services Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must be able to give voluntary written (patients may not be able to write) consent.
  2. Must be able to understand study information provided to him.
  3. CKD patients of stage IV and ESRD with age 18 to 65 years.
  4. Patient should be afebrile 24 hours prior to procedure.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Acute Renal Failure
  • Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
  • Haemoglobin level below 8g %
  • Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
  • Known bleeding or coagulation disorder.
  • Known hematologic disease
  • Poorly controlled hypertension
  • Evidence of active malignancy within one year prior to randomization.
  • Severe skin infection or osteomyelitis - the site of bone marrow aspiration potentially limiting the procedure.
  • Have a known allergy to iodinated contrast
  • Positive test results for HIV and AIDS complex, HCV, HbsAg and Syphilis.
  • History of drug or alcohol abuse
  • Patients on immunosuppressive therapy
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Autologous bone marrow stem cells

    Other: Autologous bone marrow stem cells

Interventions

  • OtherAutologous bone marrow stem cells

    Bone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery.

06

What researchers measure

Primary outcomes

  1. Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%)

    Time frame: 1 year

  2. Number of patients reporting adverse effects as a measure of safety and tolerability

    Time frame: 1 year

Secondary outcomes

  1. Improvement in renal biopsy

    Time frame: 1 year

07

Study locations

1 site
  • St. Theresa's Hospital
    Bengaluru, Karnataka 560010, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01152411
Lead sponsor
International Stemcell Services Limited
Responsible party
Sponsor
First posted
Jun 29, 2010
Start date
Feb 2010
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Mar 29, 2012

Study contacts

Balakrishna S, M.B.B.S
study director · International Stemcell Services Limited

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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